Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer

Sponsor
CytoDyn, Inc.
Study ID
NCT05730673
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • 700mg leronlimab weekly dose — DRUG
    leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5
  • 80mg Regorafenib at week 1 — DRUG
    Regorafenib is a small-molecule multiple kinase inhibitor
  • 120mg Regorafenib at week2 — DRUG
    Regorafenib is a small-molecule multiple kinase inhibitor
  • 160 mg Regorafenib at week 3 — DRUG
    Regorafenib is a small-molecule multiple kinase inhibitor

Study Details

This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

Key Dates

Start date
Sep 20, 2022
Status verified
Feb 2023
Primary completion
May 27, 2023
Completion
Aug 10, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Leronlimab in combinatiob with Regorafenib
    Leronlimab (PRO 140) will be administered subcutaneously at a weekly dose of 700 mg in combination with staring dose of 80 mg Regorafenib at first week of the Cycle 1, followed by escalation of Regorafenib dose to 120 mg and 160 mg in second and third weeks of Cycle 1, respectively. No Regorafenib will be administered during the fourth week.

Primary Outcome Measure

Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)) in subjects with CCR5+ mCRC treated with Leronlimab (PRO 140) and Regorafenib. [ Time Frame: Four weeks ]

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