Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC

Part of paid clinical trials in San Francisco, California.

Sponsor
CytoDyn, Inc.
Study ID
NCT03838367
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 350 mg leronlimab — DRUG
    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
  • 525 mg leronlimab — DRUG
    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
  • 700 mg leronlimab — DRUG
    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
  • AUC 5 Carboplatin — DRUG
    Carboplatin is an anticancer drug chemotherapy drug.
  • Maximum Tolerated Dose (MTD) of leronlimab — DRUG
    The decision on the MTD will be made following the results obtained from Phase I studies

Study Details

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).

Key Dates

First listed
Feb 12, 2019
Start date
Apr 22, 2019
Status verified
Aug 2025
Primary completion
Jul 15, 2022
Completion
Sep 16, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: Phase II- MTD to be established for the combination treatment
    MTD PRO 140 SC + AUC 5 Carboplatin

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5 [ Time Frame: From treatment cycle 1 day 1 (C1D1) until MTD reached (each cycle being 3 weeks), up to 26 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Quest Clinical ResearchSan FranciscoCalifornia94115-
CD07 Investigational SiteChicagoIllinois60611-

Find similar trials in San Francisco, CA

By research site
Quest Clinical Research· San Francisco, CACD07 Investigational Site· Chicago, IL

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