Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Leronlimab

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

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.

leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5

700mg leronlimab weekly dose

Regorafenib is a small-molecule multiple kinase inhibitor

80mg Regorafenib at week 1

120mg Regorafenib at week2

160 mg Regorafenib at week 3

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

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.

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)

Amarex Clinical Research

CytoDyn, Inc.

Spots Global Cancer Trial Database for 160 mg regorafenib at week 3