CR6086

DRUG4 trials

Sponsors

Gruppo Oncologico Del Nord Ovest, Rottapharm Biotech S.r.l., Rottapharm Biotech

Conditions

Gastric CancerMetastatic GI CancersMetastatic Microsatellite-stable Colorectal CancerMismatch Repair Protein ProficientMolecularly selected and resectable primary colorectal cancerPretreated mismatch-repair-proficient and microsatellite stable metastatic colorectal cancerRefractory Metastatic Colorectal CancerRheumatoid Arthritis, DMARD-naive and Early Disease Patients

Phase 1

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

Active, not recruitingNCT05205330

Rottapharm BiotechGastric Cancer, Metastatic GI Cancers, Metastatic Microsatellite-stable Colorectal Cancer +3

Start: 2021-11-23End: 2027-06-30Target: 107Updated: 2025-10-29

AN OPEN-LABEL, SINGLE-ARM, PHASE IB/IIA TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE EP4 RECEPTOR ANTAGONIST VORBIPIPRANT (CR6086) IN COMBINATION WITH THE PD-1 INHIBITOR BALSTILIMAB (AGEN2034), IN PATIENTS WITH PRETREATED MISMATCH-REPAIR-PROFICIENT AND MICROSATELLITE STABLE METASTATIC COLORECTAL CANCER, AND OTHER METASTATIC GI CANCERS.

Active, not recruitingCTIS2024-515446-16-00

Rottapharm Biotech S.r.l.and other metastatic GI cancers, Pretreated mismatch-repair-proficient and microsatellite stable metastatic colorectal cancer

Start: 2021-11-23Target: 55Updated: 2025-12-02

Phase 2

A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

CompletedNCT03163966

Rottapharm BiotechRheumatoid Arthritis, DMARD-naive and Early Disease Patients

Start: 2017-10-05End: 2019-01-08Updated: 2021-10-05

WINDOW-OF-OPPORTUNITY UMBRELLA PLATFORM TRIAL OF SHORT-COURSE PRE-OPERATIVE OR NEOADJUVANT TARGETED TREATMENT IN PATIENTS WITH MOLECULARLY SELECTED AND RESECTABLE PRIMARY COLORECTAL CANCER: THE UNICORN STUDY

RecruitingCTIS2022-501308-90-00

Gruppo Oncologico Del Nord OvestMolecularly selected and resectable primary colorectal cancer

Start: 2023-05-24Target: 112Updated: 2025-10-07

Related Papers

Phase I/II study of the EP4 antagonist vorbipiprant combined with anti-PD-1 immunotherapy: Safety and efficacy results in metastatic gastrointestinal non-colorectal cancers.

Journal of Clinical Oncology2025-05-28

Preoperative botensilimab (BOT) with or without balstilimab (BAL) for patients with resectable locally advanced pMMR or dMMR colon cancer: Results from the UNICORN trial by GONO.

Journal of Clinical Oncology2025-01-274 citations

Updated results and subgroup analysis by presence of liver metastases of a phase I/II study of the EP4 antagonist vorbipiprant with the anti-PD-1 balstilimab in mismatch-repair-proficient and microsatellite stable (pMMR/MSS) chemorefractory metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2024-06-011 citations