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

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT05836324

Run by

Incyte Corporation

People needed

570

Starts

2023-07-24

Expected to finish

2029-05-03

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust — Newcastle upon Tyne, United Kingdom (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Cancer and Hematology Centers of Western Michigan-Start Midwest — Grand Rapids, Michigan, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Nyu Langone Health - Long Island Hospital — Mineola, New York, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Lifespan Cancer Research Institute — Providence, Rhode Island, United States (enrolling)
• University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (enrolling)
• Imperial College Healthcare Nhs Trust - Hammersmith Hospital — London, United Kingdom (enrolling)
• The Christie Nhs Foundation Trust Uk — Manchester, United Kingdom (enrolling)
• The Angeles Clinic and Research Institute — Los Angeles, California, United States (enrolling)
• Rigshospitalet Uni of Hospital of Copenhagen — Copenhagen, Denmark (enrolling)
• Herlev Og Gentofte Hospital — Herlev, Denmark (enrolling)
• Odense University Hospital — Odense C, Denmark (enrolling)
• Vejle Hospital — Vejle, Denmark (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• Fondazione Irccs Istituto Nazionale Dei Tumori — Milan, Italy (enrolling)
• Irccs Istituto Clinico Humanitas — Rozzano, Italy (enrolling)
• Centro Ricerche Cliniche Di Verona — Verona, Italy (enrolling)
• Kansai Medical University Hospital — Hirakata, Japan (enrolling)
• National Cancer Center Hospital — Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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