NCT05730673

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

A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This ia a phase II, single arm study with 30 patients in order to test the hypothesis that the combination of Leronlimab (PRO 140) SC and oral Regorafenib will increase PFS in patients with CCR5 + MSS mCRC. Leronlimab 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.

Conditions

• CCR5
• Microsatellite Stable
• Metastatic
• Colorectal Cancer

Interventions

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

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-05-27
• Completion: 2023-08-10
• First posted: 2023-02-16
• Last updated: 2023-02-17

Regulatory

• FDA-regulated drug study