Recruiting
Phase 1

INCA33890

Sponsor:

Incyte Corporation

Code:

NCT05836324

Conditions

Solid Tumors

Advanced Solid Tumors

Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA33890

bevacizumab

FOLFIRI

FOLFOX

Cetuximab

Study Details

Brief summary:

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Conditions

Solid Tumors

Advanced Solid Tumors

Metastatic Solid Tumors

Study ID

NCT05836324

Start date

Jul 24, 2023

Status verified date

Jul, 2026

Completion date

May 3, 2029

Anticipated

Primary completion date

May 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥18 years old
  • Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
  • Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.
  • ECOG performance status score of 0 or 1.
  • Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.
  • Presence of measurable disease according to RECIST v1.1.

Exclusion Criteria:

  • Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.
  • Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
  • Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.
  • Brain or CNS metastases untreated or that have progressed.
  • History of organ transplant, including allogeneic stem cell transplantation.
  • History of clinically significant or uncontrolled cardiac disease.
  • Active HBV, active HCV, or HIV positive.
  • Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
  • Significant concurrent, uncontrolled medical condition, eg:

  • Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.
  • Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.
  • Participants with adequate laboratory values within the protocol defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Enrollment

570 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a - Dose Escalation Monotherapy

INCA33890 will be administered at the protocol-defined dose based on cohort assignment.

experimental: Part 1b-Dose Expansion Monotherapy

INCA33890 will be administered at the protocol-defined dose based on cohort assignment.

experimental: Part 2a - Dose Escalation Combination Therapy - Group 1

INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.

experimental: Part 2a - Dose Escalation Combination Therapy - Group 2

INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.

experimental: Part 2a - Dose Escalation Combination Therapy - Group 3

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.

experimental: Part 2a - Dose Escalation Combination Therapy - Group 4

INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.

experimental: Part 2a - Dose Escalation Combination Therapy - Group 5

INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.

experimental: Part 2b - Dose Expansion Combination Therapy - Group 1

INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.

experimental: Part 2b - Dose Expansion Combination Therapy - Group 2

INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.

experimental: Part 2b - Dose Expansion Combination Therapy - Group 3

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.

experimental: Part 2b - Dose Expansion Combination Therapy - Group 4

INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.

experimental: Part 2b - Dose Expansion Combination Therapy - Group 5

INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.

Interventions

INCA33890

INCA33890 will be administered at protocol defined dose.

bevacizumab

Bevacizumab will be administered at protocol defined dose.

FOLFIRI

FOLFIRI will be administered at protocol defined dose.

FOLFOX

FOLFOX will be administered at protocol defined dose.

Cetuximab

Cetuximab will be administered at protocol defined dose.

ADG126

ADG126 will be administered at protocol defined dose.

Primary outcome measure

  • Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Treatment Emerging Adverse Events (TEAEs) [ Time Frame: Up to 2 years ]
  • TEAEs leading to dose modification or discontinuation [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Cancer and Hematology Centers of Western Michigan-Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Nyu Langone Health - Long Island Hospital

Recruiting

Mineola, New York, United States, 11501

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Lifespan Cancer Research Institute

Recruiting

Providence, Rhode Island, United States, 02903

University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

South Texas Accelerated Research Therapeutics

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Incyte Corporation

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Solid Tumors
  • INCA33890

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-07-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.