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Alkylating agents
Maximum Tolerated Dose (MTD) of leronlimab for Breast Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by CytoDyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a histologically confirmed diagnosis of TNBC. Must demonstrate HER-2 negative (IHC 0, 1+, or fluorescence in situ hybridization (FISH) negative and ER<1%, and PR < 1%, per ASCO/CAP criteria);
Demonstrate CCR5 + by IHC (>10% membranous staining completed at the reference laboratory of Dr. Hallgeir Rui at Medical College of Wisconsin).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
Awards & highlights
Study Summary
Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC
Eligible Conditions
- Breast Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.
Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5
Secondary outcome measures
Phase I: The number, frequency, and severity of adverse events (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.
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 leronlimab (PRO 140) and carboplatin.
Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death;
+4 moreOther outcome measures
Correlation between CCR5 expression (CTCs, CAMLs) and PD- L1 expression.
Measure immune biomarkers (PD-L1) in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit (PFS)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase II- MTD to be established for the combination treatmentExperimental Treatment2 Interventions
MTD PRO 140 SC + AUC 5 Carboplatin in 30 subjects
Group II: Phase I-Cohort C: 700 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimental Treatment2 Interventions
Cohort C: 700 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Group III: Phase I-Cohort B: 525 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimental Treatment2 Interventions
Cohort B: 525 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Group IV: Phase I-Cohort A: 350 mg PRO 140 SC weekly + AUC 5 CarboplatinExperimental Treatment2 Interventions
Cohort A: 350 mg PRO 140 SC weekly + AUC 5 Carboplatin every 3 weeks
Find a Location
Who is running the clinical trial?
CytoDyn, Inc.Lead Sponsor
23 Previous Clinical Trials
2,510 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,617 Total Patients Enrolled
Frequently Asked Questions
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