Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CR6086 · 1 trial · 6 indications
Incidence of TEAEs using NCI CTCAE v5.0
Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part
Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa)
| Arm | Type | Description |
|---|---|---|
| 30 mg (Dose Level 1) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 30 mg twice a day for 14 days |
| 90 mg (Dose Level 2) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| 180 mg (Dose Level 3) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 180 mg twice a day for 14 days |
| other mGI cancers | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Expansion in MSS/pMMR mCRC patients | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Name | Type | Description |
|---|---|---|
| CR6086 | DRUG | oral CR6086, twice a day for 14 days |
| AGEN2034 | BIOLOGICAL | AGEN2034 3 mg/Kg iv on D1 of each 14- day cycle |
Diagnosis and Main Criteria for Inclusion/Exclusion: Inclusion Criteria Main Study - patients with MSS mCRC These criteria are applicable for both Dose Escalation and Expansion part of the Main Study; criteria specific for each study part are identified with ESC=Escalation or EXP=Expansion. 1. Si...
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CR6086 is an investigational small molecule being studied for refractory metastatic colorectal cancer, specifically in patients with proficient mismatch repair and microsatellite-stable tumors. It is also being evaluated in other metastatic gastrointestinal cancers, including gastric cancer, as part of a combination therapy.
CR6086 targets the EP4 receptor, a subtype of the prostaglandin E2 receptor. By binding to EP4, the drug is designed to modulate signaling pathways involved in tumor progression and immune evasion, which is relevant in the oncology setting.
CR6086 is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AGEN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in combination with other agents for advanced gastrointestinal cancers.
CR6086 is currently in Phase 1 clinical development. The ongoing trial is a Phase 1 study investigating the drug in combination with balstilimab for stage IV refractory colorectal cancer and other metastatic GI cancers. It is not yet approved and remains investigational.
CR6086 is being studied in a Phase 1 trial with the identifier NCT05205330. This trial evaluates vorbipiprant (CR6086) combined with balstilimab (AGEN2034) in patients with refractory metastatic colorectal cancer and other metastatic GI cancers. The study is active but not recruiting, with an enrollment of 107 participants in Italy.
Yes, CR6086 is also known as vorbipiprant. In clinical trial records, the drug is referred to by both names, with vorbipiprant being the generic name and CR6086 the code name used during development.