Trial Outcomes & Findings for A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (NCT NCT04907851)
NCT ID: NCT04907851
Last Updated: 2025-03-17
Results Overview
The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
At 6 months
Results posted on
2025-03-17
Participant Flow
This study was conducted from 10 December 2021 to 22 Nov 2023 at multiple centers in Australia, and United Kingdom.
Patients who met the inclusion criteria, and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the Schedule of Assessment.
Participant milestones
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \[QD\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
20
|
19
|
|
Overall Study
COMPLETED
|
0
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
10
|
Reasons for withdrawal
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \[QD\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Overall Study
Consent withdrawn
|
1
|
2
|
0
|
|
Overall Study
Death
|
5
|
15
|
10
|
Baseline Characteristics
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
Baseline characteristics by cohort
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 7.94 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 14.72 • n=107 Participants
|
58.1 years
STANDARD_DEVIATION 10.85 • n=206 Participants
|
58.1 years
STANDARD_DEVIATION 12.61 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months
|
NA percentage of participants
The estimate of PFS at 6-months could not be calculated as the final surviving patient withdrew consent and was censored at 2.73 months. The Kaplan-Meier survival curve, from which the estimates would have been derived, did not extend to 6-months.
|
6.1 percentage of participants
Interval 0.73 to 20.53
|
—
|
PRIMARY outcome
Timeframe: Up to 23 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The anti-tumour activity of RXC004 as a combination therapy was assessed. ORR was defined as the percentage of patients with a best overall response of complete response or partial response based on local investigator assessment as defined in RECIST 1.1.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=19 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Combination Therapy (Module 3): Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 14.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The preliminary efficacy of RXC004 was assessed. ORR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2): ORR
|
16.7 percentage of participants
Interval 0.85 to 58.18
|
5.0 percentage of participants
Interval 0.26 to 21.61
|
—
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. DCR was defined as the percentage of patients with a best overall response of either CR, PR or stable disease (SD) for at least 6 weeks.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Disease Control Rate (DCR)
|
16.7 percentage of participants
Interval 0.85 to 58.18
|
25.0 percentage of participants
Interval 10.41 to 45.56
|
31.6 percentage of participants
Interval 14.75 to 53.0
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): PFS
|
1.4 months
Interval 0.72 to
Due to insufficient number of participants with events, estimates were not calculable using methodology specified in SAP.
|
1.4 months
Interval 1.38 to 2.04
|
1.41 months
Interval 1.41 to 2.53
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. The best percentage change in tumour size was determined at a patient level. For each patient, it represents the largest decrease (or smallest increase) in tumour size. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of all target lesions.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=5 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=17 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Best Percentage Change in Tumor Size
|
41.67 Percentage change in tumour size
Interval -57.1 to 93.2
|
20.06 Percentage change in tumour size
Interval -78.8 to 87.9
|
30.61 Percentage change in tumour size
Interval -33.3 to 61.3
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Full Analysis Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. OS was defined as the time from first day of study treatment until death due to any cause.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Overall Survival (OS)
|
5.3 Months
Interval 0.7 to
Due to insufficient number of participants with events, estimates were not calculable using methodology specified in SAP.
|
7.1 Months
Interval 3.5 to 13.6
|
4.7 Months
Interval 2.9 to
Due to insufficient number of participants with events, therefore data was not calculated as per methodology specified in SAP.
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The pharmacokinetics (PK) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=17 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 0 Day 1
|
107 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.4
|
78.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43.9
|
57.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44.1
|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 1 Day 15
|
140 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.8
|
99.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.7
|
67.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.8
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (tmax) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=17 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Time to Cmax (Tmax)
Cycle 0 Day 1
|
1.49 hour (h)
Geometric Coefficient of Variation 36.3
|
1.44 hour (h)
Geometric Coefficient of Variation 51.3
|
1.66 hour (h)
Geometric Coefficient of Variation 45.9
|
|
Time to Cmax (Tmax)
Cycle 1 Day 15
|
1.49 hour (h)
Geometric Coefficient of Variation 36.3
|
1.44 hour (h)
Geometric Coefficient of Variation 51.3
|
1.66 hour (h)
Geometric Coefficient of Variation 45.9
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 15 (The cycle was 21 days in length) (Up to 23 months)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (Cmin) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=5 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=17 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Minimum Observed Concentration Across the Dosing Interval (Cmin)
|
22.0 ng/mL
Geometric Coefficient of Variation 37.5
|
19.5 ng/mL
Geometric Coefficient of Variation 110
|
9.79 ng/mL
Geometric Coefficient of Variation 153
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 (The cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (λz) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=15 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Terminal Rate Constant (λz)
|
0.0660 one per hour (1/h)
Geometric Coefficient of Variation 36.5
|
0.0660 one per hour (1/h)
Geometric Coefficient of Variation 32.4
|
0.0655 one per hour (1/h)
Geometric Coefficient of Variation 28.0
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1(The cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (t½) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=15 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Terminal Half-life (t½)
|
10.5 hour (h)
Geometric Coefficient of Variation 36.5
|
9.90 hour (h)
Geometric Coefficient of Variation 27.6
|
10.6 hour (h)
Geometric Coefficient of Variation 29.0
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 (The cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (AUC0-∞) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=15 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
|
891 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.8
|
690 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 43.5
|
511 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.0
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 (The cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK(CL/F) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=15 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Total Plasma Clearance After Oral Administration (CL/F)
|
2250 milliliter per hour (mL/h)
Geometric Coefficient of Variation 21.8
|
2900 milliliter per hour (mL/h)
Geometric Coefficient of Variation 43.5
|
2940 milliliter per hour (mL/h)
Geometric Coefficient of Variation 47.0
|
SECONDARY outcome
Timeframe: At Cycle 0 Day 1 (The cycle was 21 days in length)Population: PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.
The PK (Vz/F) of RXC004 as a monotherapy and as a combination therapy was assessed.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=16 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=15 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Apparent Volume of Distribution After Oral Administration (Vz/F)
|
29700 milliliter (mL)
Geometric Coefficient of Variation 28.9
|
41400 milliliter (mL)
Geometric Coefficient of Variation 31.0
|
44800 milliliter (mL)
Geometric Coefficient of Variation 40.4
|
SECONDARY outcome
Timeframe: From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)Population: Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.
The safety, and tolerability profile of RXC004 as a monotherapy and as a combination therapy was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.
Outcome measures
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 Participants
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 Participants
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.
|
|---|---|---|---|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to permanent discontinuation or 0 6 interruption of Pembrolizumab
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to permanent discontinuation of 0 5 Pembrolizumab
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to interruption of Pembrolizumab
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
Grade >=3 TEAE
|
4 Participants
|
8 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events (AEs)
Serious TEAE
|
3 Participants
|
6 Participants
|
11 Participants
|
|
Number of Patients With Adverse Events (AEs)
Related Serious TEAE
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to death
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to permanent discontinuation of RXC004
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to reduction of RXC004
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to interruption of RXC004
|
0 Participants
|
9 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events (AEs)
Treatment-Emergent Adverse Event (TEAE)
|
6 Participants
|
20 Participants
|
19 Participants
|
|
Number of Patients With Adverse Events (AEs)
Related TEAE
|
4 Participants
|
17 Participants
|
18 Participants
|
|
Number of Patients With Adverse Events (AEs)
Related grade>=3 TEAE
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE leading to permanent discontinuation or reduction or interruption of RXC004
|
3 Participants
|
10 Participants
|
11 Participants
|
Adverse Events
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 15 deaths
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
Serious events: 11 serious events
Other events: 19 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 participants at risk
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \[QD\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 participants at risk
Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 participants at risk
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastric haemorrhage
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Endocrine disorders
Immune-mediated adrenal insufficiency
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Stoma site abscess
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Product Issues
Device occlusion
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
Other adverse events
| Measure |
Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
n=6 participants at risk
Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \[QD\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.
|
Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
n=20 participants at risk
Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.
|
Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
n=19 participants at risk
Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
25.0%
5/20 • Number of events 8 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
40.0%
8/20 • Number of events 9 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
31.6%
6/19 • Number of events 8 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
20.0%
4/20 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.8%
3/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
50.0%
10/20 • Number of events 11 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
26.3%
5/19 • Number of events 5 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.8%
3/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
31.6%
6/19 • Number of events 6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Dysgeusia
|
83.3%
5/6 • Number of events 5 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
65.0%
13/20 • Number of events 14 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
63.2%
12/19 • Number of events 13 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
65.0%
13/20 • Number of events 14 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
26.3%
5/19 • Number of events 5 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
45.0%
9/20 • Number of events 9 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
42.1%
8/19 • Number of events 9 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
20.0%
4/20 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.8%
3/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood calcium increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
21.1%
4/19 • Number of events 4 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.0%
3/20 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.8%
3/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
15.8%
3/19 • Number of events 3 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.0%
2/20 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/19 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.0%
1/20 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
10.5%
2/19 • Number of events 2 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/6 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
0.00%
0/20 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
5.3%
1/19 • Number of events 1 • From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].
Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3. All the AEs from Screening till study termination have been presented here before, and after receiving treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place