Trial Outcomes & Findings for Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer (NCT NCT05177770)
NCT ID: NCT05177770
Last Updated: 2025-05-08
Results Overview
Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types. * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Results posted on
2025-05-08
Participant Flow
A total of 16 participants were enrolled. 1 participant discontinued due to an adverse event prior to the first dose and was therefore not included in the analyses. 15 participants received study treatment and were included in the analyses.
Participant milestones
| Measure |
SRF617 + Etrumadenant + Zimberelimab
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 milligrams (mg) intravenously (IV) every 2 weeks (q2) on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV every 4 weeks (q4) on Day 1
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
SRF617 + Etrumadenant + Zimberelimab
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 milligrams (mg) intravenously (IV) every 2 weeks (q2) on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV every 4 weeks (q4) on Day 1
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event prior to dosing
|
1
|
Baseline Characteristics
Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=15 Participants
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.16 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug.
Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types. * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters
Outcome measures
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=15 Participants
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Number of Participants With Response
|
0 Participants
|
PRIMARY outcome
Timeframe: From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)Population: The Safety Analysis Set included all participants who received any amount of study drug
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=15 Participants
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
15 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
The number of participants achieving CR or PR by PCWG3 criteria is reported: * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters * Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions from the smallest value on trial (including Baseline, if that is the smallest). The sum of diameters must also demonstrate an absolute increase of at least 5 mm. Or, the appearance of one or more lesions * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug.
PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.
Outcome measures
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=15 Participants
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Number of Participants With PSA50 Response
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 6 and 12Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)Population: Analysis was not performed as data were not collected for this outcome measure due to early study termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)Population: The Safety Analysis Set included all participants who received any amount of study drug
Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported.
Outcome measures
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=15 Participants
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Number of Participants With Symptomatic Skeletal Events (SSEs)
|
4 Participants
|
Adverse Events
SRF617 + Etrumadenant + Zimberelimab
Serious events: 7 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=16 participants at risk
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
Nervous system disorders
Spinal cord compression
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Disease progression
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
Other adverse events
| Measure |
SRF617 + Etrumadenant + Zimberelimab
n=16 participants at risk
SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:
* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1
|
|---|---|
|
General disorders
Fatigue
|
37.5%
6/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Chest pain
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Chills
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
General physical health deterioration
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Malaise
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
3/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Oesophageal pain
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Weight decreased
|
18.8%
3/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Blood creatinine increased
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Lipase increased
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Amylase increased
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
International normalised ratio increased
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Investigations
Lymphocyte count increased
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
6/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Nervous system disorders
Anosmia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Nervous system disorders
Cognitive disorder
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Psychiatric disorders
Insomnia
|
25.0%
4/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Psychiatric disorders
Delirium
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Vascular disorders
Hypotension
|
25.0%
4/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Infections and infestations
Soft tissue infection
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Eye disorders
Eyelid function disorder
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
4/16 • From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.
|
Additional Information
Allison Intondi, Vice President, Clinical Operations
Coherus BioSciences
Phone: 800-794-5434
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place