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A Phase Ib/IIa Study of CR6086 in Combination With Balstilimab in pMMR-MSS Metastatic Colorectal Cancer Patients

Solid Tumor Clinical Trial

Official title:
An Open-label, Single-arm, Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of the EP4 Receptor Antagonist CR6086 in Combination With the PD-1 Inhibitor Balstilimab (AGEN2034), in Patients With Pretreated Mismatch-repair-proficient and Microsatellite Stable Metastatic Colorectal Cancer

Clinical Trial Summary

This Phase Ib/IIa study has been designed according to a 3+3 dose escalation/dose expansion design. A dose expansion will be conducted at both the intermediate and high dose levels, if tolerated, with the purpose of generating additional and more robust safety and preliminary efficacy data. No control arm was included, as the target patient population of this study consists of patients in whom the overall survival is less than 6 months and treatment options are very limited and often poorly tolerated, making unlikely that the study results can be significantly biased.

Clinical Trial Description

In this study, the combination of the PGE2 inhibition (through the EP4 receptor antagonist CR6086) with the immune checkpoint blockade (through the anti-PD-1 AGEN2034) is being evaluated. CR6086 is a potent and selective, orally bioavailable, targeted immunomodulator small molecule acting as an EP4 receptor antagonist. AGEN2034 (balstilimab) is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block programmed cell death 1 (PD-1) from interacting with its ligands (PD-L) PD-L1 and PD-L2, currently being developed for the treatment of advanced malignancies. EP4 receptor antagonists turn the status of the tumor microenvironment into a favourable one, i.e. immune-responsive, representing thus a rational therapeutic approach in combination with ICIs in primarily refractory cancers. ;

Study Design

Related Conditions & MeSH terms

  • Colorectal Neoplasms
  • Metastatic Microsatellite-stable Colorectal Cancer
  • Mismatch Repair Protein Proficient
  • Refractory Metastatic Colorectal Cancer
  • Solid Tumor
Clinical Trial Details
NCT number NCT05205330
Study type Interventional
Source Rottapharm Biotech
Contact Clinical Operations Director Rottapharm Biotech
Phone +390399066065
Email nadia.brambilla@rottapharmbiotech.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 23, 2021
Completion date December 2024
View Details
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