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CR6086

Phase 1

Refractory Metastatic Colorectal Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Oct 29, 2025

Target and mechanism

Molecular targetEP4
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

CR6086 · 1 trial · 6 indications

Phase 1 1
NCT05205330Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI CancersRefractory Metastatic Colorectal Cancer
ACTIVE NOT_RECRUITING107 Analytics
PHASE1ACTIVE NOT_RECRUITING
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
Refractory Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of CR6086 combined with AGEN2034
From the time of the first dose up to 24 weeks of treatment

Incidence of TEAEs using NCI CTCAE v5.0

Disease Control rate (DCR)
up to 24 weeks of treatment

Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part

Objective Response Rate (ORR)
up to 24 weeks of treatment

Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa)

Secondary Endpoints

Disease Control Rate (DCR)
throughout the study
Objective Response Rate (ORR)
throughout the study
Duration Of Response (DOR)
throughout the study, up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
30 mg (Dose Level 1)EXPERIMENTAL14-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)EXPERIMENTAL14-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)EXPERIMENTAL14-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 cancersEXPERIMENTAL14-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 patientsEXPERIMENTAL14-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

Interventions

NameTypeDescription
CR6086DRUGoral CR6086, twice a day for 14 days
AGEN2034BIOLOGICALAGEN2034 3 mg/Kg iv on D1 of each 14- day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:Italy
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Refractory Metastatic Colorectal Cancer")

Frequently asked questions about CR6086

What is CR6086 used for?

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.

What does CR6086 target?

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.

Who is developing CR6086?

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.

What phase is CR6086 in?

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.

What clinical trials is CR6086 in?

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.

Is CR6086 the same as vorbipiprant?

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.