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

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

Related Studies