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INCA33890

Phase 3

CRC (Colorectal Cancer) | Small molecule | Oncology |Incyte Corporation|Last Updated: Aug 6, 2026

Target and mechanism

Molecular targetTGFβR2xPD-1
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment700

FDA Designations

No designations recorded

Clinical trial landscape

INCA33890 · 2 trials · 4 indications

Phase 3 1Phase 1 1
NCT07284849A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal CancerCRC (Colorectal Cancer)
RECRUITING700 Analytics
PHASE3RECRUITING
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
CRC (Colorectal Cancer)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS)
Up to 3 years

Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.

Dose Limiting Toxicities (DLTs)
Up to 28 days
Treatment Emerging Adverse Events (TEAEs)
Up to 2 years
TEAEs leading to dose modification or discontinuation
Up to 2 years

Secondary Endpoints

Overall Survival (OS)
Up to 4 years
Objective response
Up to 3 years
Duration of Response (DOR)
Up to 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCA33890EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
PlaceboPLACEBO_COMPARATORPlacebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
Part 1a - Dose Escalation MonotherapyEXPERIMENTALINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Part 1b-Dose Expansion MonotherapyEXPERIMENTALINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 1EXPERIMENTALINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 2EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 3EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 4EXPERIMENTALINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 5EXPERIMENTALINCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 1EXPERIMENTALINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 2EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 3EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 4EXPERIMENTALINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 5EXPERIMENTALINCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.

Interventions

NameTypeDescription
INCA33890DRUGINCA33890 will be administered at protocol defined dose.
PlaceboDRUGPlacebo will be administered at protocol defined dose.
BevacizumabDRUGBevacizumab will be administered at protocol defined dose.
FOLFOXDRUGFOLFOX will be administered at protocol defined dose.
FOLFIRIDRUGFOLFIRI will be administered at protocol defined dose.
CetuximabDRUGCetuximab will be administered at protocol defined dose.
ADG126DRUGADG126 will be administered at protocol defined dose.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites254

Inclusion Criteria: * Stage IV colorectal adenocarcinoma not amenable to curative resection. * No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaDenmarkFranceGeorgiaGermanyItalyJapanNetherlandsNorwayPolandPuerto RicoSouth KoreaSpainSwitzerlandUnited KingdomChina
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Competitive Landscape -Colorectal Cancer 257 trials (matched to "CRC (Colorectal Cancer)")

Recent Changes (Last 90 Days)

LOWAug 6, 2026NCT07284849lastUpdatePostDate: changed
LOWAug 6, 2026NCT07284849lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT05836324Enrollment: 408 → 570
LOWJul 24, 2026NCT07284849lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT05836324Enrollment: 408 → 570
LOWJul 24, 2026NCT07284849lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284849lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284849lastUpdatePostDate: changed
LOWJul 6, 2026NCT07284849lastUpdatePostDate: changed
LOWJul 6, 2026NCT07284849lastUpdatePostDate: changed
LOWJun 30, 2026NCT07284849lastUpdatePostDate: changed
LOWJun 30, 2026NCT07284849lastUpdatePostDate: changed
LOWJun 30, 2026NCT07284849lastUpdatePostDate: changed

Frequently asked questions about INCA33890

What is INCA33890 used for in CRC (Colorectal Cancer)?

INCA33890 is an investigational small molecule being studied for the first-line treatment of metastatic microsatellite stable colorectal cancer, in combination with standard-of-care chemotherapy and bevacizumab. It is also being evaluated in a Phase 1 study for advanced or metastatic solid tumors. The drug is not yet approved and remains in clinical development.

What does INCA33890 target?

INCA33890 targets TGFβR2xPD-1, a bispecific mechanism that engages both transforming growth factor beta receptor 2 and programmed cell death protein 1. This dual targeting is designed to modulate immune and tumor signaling pathways relevant to oncology. The drug is a small molecule being developed by Incyte Corporation.

Who makes INCA33890?

INCA33890 is developed by Incyte Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker INCY. Incyte is conducting clinical trials of INCA33890 in oncology indications, including colorectal cancer and other solid tumors.

What phase is INCA33890 in?

INCA33890 is in Phase 3 clinical development for metastatic microsatellite stable colorectal cancer, based on a recruiting Phase 3 trial. It is also being studied in an earlier Phase 1 trial for advanced or metastatic solid tumors. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is INCA33890 in?

INCA33890 is being evaluated in two recruiting trials. NCT07284849 is a Phase 3 study testing the drug with chemotherapy and bevacizumab in first-line metastatic microsatellite stable colorectal cancer, enrolling 700 participants. NCT05836324 is a Phase 1 safety study in advanced or metastatic solid tumors, enrolling 570 participants across multiple countries.

Is INCA33890 the same as another drug?

No alternative names for INCA33890 have been disclosed. The drug is identified solely by its code name INCA33890 in clinical trial registries and by its developer, Incyte Corporation. It is a distinct investigational small molecule targeting TGFβR2xPD-1.