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A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

RecruitingPhase 1

A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Incyte Corporation · Participants: 570 · Started: Jul 24, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05836324

Locations in the U.S.

CaliforniaThe Angeles Clinic and Research Institute, Los Angeles
Valkyrie Clinical Trials, Los Angeles
MassachusettsDana Farber Cancer Institute, Boston
MichiganCancer and Hematology Centers of Western Michigan-Start Midwest, Grand Rapids
New JerseyHackensack University Medical Center, Hackensack
New YorkNyu Langone Health - Long Island Hospital, Mineola
Laura and Isaac Perlmutter Cancer Center, New York
PennsylvaniaUniversity of Pennsylvania, Philadelphia
Rhode IslandLifespan Cancer Research Institute, Providence
TexasUniversity of Texas Md Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics, San Antonio

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.