Trial Outcomes & Findings for Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC (NCT NCT03838367)
NCT ID: NCT03838367
Last Updated: 2025-09-09
Results Overview
The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in \>= 33% of the participants.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From treatment cycle 1 day 1 (C1D1) until MTD reached (each cycle being 3 weeks), up to 26 weeks
Results posted on
2025-09-09
Participant Flow
Study was early terminated, and no participants were enrolled to the Phase II arm of the trial.
Participant milestones
| Measure |
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
350 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
350 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Overall Study
Early termination of study
|
3
|
4
|
3
|
0
|
Baseline Characteristics
No height data was collected for 2 participants.
Baseline characteristics by cohort
| Measure |
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 Participants
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
350 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=4 Participants
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 Participants
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
—
|
8 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
—
|
2 Participants
n=10 Participants
|
|
Age, Continuous
|
41.67 years
STANDARD_DEVIATION 7.76 • n=3 Participants
|
55.75 years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
61.67 years
STANDARD_DEVIATION 8.73 • n=3 Participants
|
—
|
53.30 years
STANDARD_DEVIATION 12.50 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
—
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
—
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
—
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
—
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
—
|
10 participants
n=10 Participants
|
|
Height
|
160.05 cm
STANDARD_DEVIATION 2.55 • n=2 Participants • No height data was collected for 2 participants.
|
162.85 cm
STANDARD_DEVIATION 6.23 • n=4 Participants • No height data was collected for 2 participants.
|
164.30 cm
STANDARD_DEVIATION 3.30 • n=2 Participants • No height data was collected for 2 participants.
|
—
|
162.51 cm
STANDARD_DEVIATION 5.11 • n=8 Participants • No height data was collected for 2 participants.
|
|
Weight
|
85.73 kg
STANDARD_DEVIATION 32.08 • n=3 Participants • No weight data was collected from 1 participant.
|
66.50 kg
STANDARD_DEVIATION 3.54 • n=4 Participants • No weight data was collected from 1 participant.
|
82.90 kg
STANDARD_DEVIATION 11.40 • n=2 Participants • No weight data was collected from 1 participant.
|
—
|
76.60 kg
STANDARD_DEVIATION 21.44 • n=9 Participants • No weight data was collected from 1 participant.
|
|
Body Mass Index (BMI)
|
24.64 kg/m2
STANDARD_DEVIATION 0.96 • n=2 Participants • No data was collected from 2 participants.
|
25.09 kg/m2
STANDARD_DEVIATION 0.91 • n=4 Participants • No data was collected from 2 participants.
|
30.58 kg/m2
STANDARD_DEVIATION 3.00 • n=2 Participants • No data was collected from 2 participants.
|
—
|
26.35 kg/m2
STANDARD_DEVIATION 2.98 • n=8 Participants • No data was collected from 2 participants.
|
PRIMARY outcome
Timeframe: From treatment cycle 1 day 1 (C1D1) until MTD reached (each cycle being 3 weeks), up to 26 weeksPopulation: The Intent-to-Treat (ITT) population (N=10) consists of all subjects who received at least one dose of leronlimab (PRO 140) and have measurable disease at baseline. The calculation of the sample size is based on the traditional 3+3 dose escalation scheme.
The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in \>= 33% of the participants.
Outcome measures
| Measure |
Phase 1b: Including 3 Dose Levels (Cohort A, Cohort B, and Cohort C)
n=10 Participants
Phase 1b is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5
|
700 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatmentPopulation: No subjects were enrolled in the Phase II portion of the trial due to early termination of the study. No data was collected for this outcome measure.
All patients who received at least one dose of leronlimab (PRO 140) and carboplatin combination was intended to be included in the primary analyses of PFS. The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria was planned to be used for objective tumor response assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1, Day 1 (each treatment cycle is 3 weeks) until last dose of study drug, up to 26 weeksPopulation: The safety population consists of all subjects who received at least one dose of leronlimab (PRO 140).
For Phase I: Adverse events followed National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This will be the Number of Participants with Any Adverse Events (AE) or Serious Adverse Events (SAE) collected from the time of first treatment until study termination to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ metastatic triple negative breast cancer.
Outcome measures
| Measure |
Phase 1b: Including 3 Dose Levels (Cohort A, Cohort B, and Cohort C)
n=3 Participants
Phase 1b is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=4 Participants
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 Participants
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Phase I: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) Collected From the Time of First Treatment Until Study Termination to Evaluate Safety of Leronlimab (PRO 140) and Carboplatin in Subjects With CCR5+ mTNBC.
Participants with any AEs
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Phase I: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) Collected From the Time of First Treatment Until Study Termination to Evaluate Safety of Leronlimab (PRO 140) and Carboplatin in Subjects With CCR5+ mTNBC.
Participants with any SAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatmentPopulation: No subjects were included in this outcome measure due to early termination of the trial.
Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) Trial was terminated prematurely and no efficacy data was collected from the Phase II portion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatmentPopulation: Study was terminated early, no safety data was collected.
Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with The trial was terminated early, efficacy data is not available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned every 6 to 9 weeks after Phase II study start, until progression or death, assessing up to 2 years after completion of treatmentPopulation: No subjects were included in this outcome measure due to early termination of the trial.
Trial was terminated prematurely and no efficacy data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.Population: No subjects were included in this outcome measure due to early termination of the trial.
Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. No efficacy data was available due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned from Day 1 to death from any cause, assessing up to 2 years after completion of treatment.Population: No subjects were included in this outcome measure due to early termination of the trial.
Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death; No efficacy data is available due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned from Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug)Population: No subjects were included in this outcome measure due to early termination of the trial.
Phase II: Number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. No safety data was available from the Phase II portion of the trial due to early termination of the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Planned every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS) No subjects were included in this outcome measure due to early termination of the trial.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Planned every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.No subjects were included in this outcome measure due to early termination of the trial.
Outcome measures
Outcome data not reported
Adverse Events
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II- MTD to be Established for the Combination Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 participants at risk
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
350 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=4 participants at risk
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 participants at risk
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
Other adverse events
| Measure |
Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 participants at risk
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
350 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort B: 525 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=4 participants at risk
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
525 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase I-Cohort C: 700 mg PRO 140 SC Weekly + AUC 5 Carboplatin
n=3 participants at risk
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
700 mg leronlimab: leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
|
Phase II- MTD to be Established for the Combination Treatment
MTD PRO 140 SC + AUC 5 Carboplatin
AUC 5 Carboplatin: Carboplatin is an anticancer drug chemotherapy drug.
Maximum Tolerated Dose (MTD) of leronlimab: The decision on the MTD will be made following the results obtained from Phase I studies
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Investigations
Platelet Count Decreased
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
50.0%
2/4 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Investigations
Neutrophil Count Decreased
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 5 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
100.0%
4/4 • Number of events 6 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
50.0%
2/4 • Number of events 3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Infections and infestations
Lymph Gland Infection
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Immune system disorders
Drug hypersensitivity
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Injury, poisoning and procedural complications
Injection Site Bruising
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Psychiatric disorders
Restlessness
|
33.3%
1/3 • Number of events 3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Nervous system disorders
Mood Swings
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 5 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Abdominal Distension
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
25.0%
1/4 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 2 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
0.00%
0/4 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
33.3%
1/3 • Number of events 1 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
—
0/0 • Adverse events were reported from the time of first treatment until the early termination of the study to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC (up to approximately 30 months).
Safety were assessed by close monitoring and timely assessment of adverse events, laboratory parameters (blood tests, urinalysis), vital signs Blood pressure, heart rate), subject's medical condition (physical examination including weight), general well-being and activities of daily life (Eastern Cooperative Oncology Group (ECOG) performance status).
|
Additional Information
Joseph Meidling - Vice President, Clinical Operations
CytoDyn
Phone: 3609808524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place