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Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers

NCT05205330 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-10-29

No results posted yet for this study

Summary

This Phase Ib/IIa study comprises a Main Study and a Study Extension.

The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients. The fixed-dose Expansion phase will be conducted at the recommended dose for expansion (RDE), with the purpose of generating additional and more robust safety and efficacy data. 27 patients are predicted in the Dose Escalation phase and 52 in the Expansion phase, respectively.

The Study Extension explores in other metastatic GI cancers the Vorbipiprant (CR6086) RDE obtained in the Main Study. 27 patients are predicted.

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.

Conditions

  • Refractory Metastatic Colorectal Cancer
  • Solid Tumor
  • Metastatic Microsatellite-stable Colorectal Cancer
  • Mismatch Repair Protein Proficient
  • Metastatic GI Cancers
  • Gastric Cancer

Interventions

DRUG

CR6086

oral CR6086, twice a day for 14 days

BIOLOGICAL

AGEN2034

AGEN2034 3 mg/Kg iv on D1 of each 14- day cycle

Sponsors & Collaborators

  • Agenus Inc.

    collaborator INDUSTRY

  • Rottapharm Biotech

    lead INDUSTRY

Principal Investigators

  • Coordinating Investigator · IRCCS Istituto Nazionale dei Tumori

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205330 on ClinicalTrials.gov