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RECRUITING

NCT05836324

PHASE1

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

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2023-07-24

Completion Date

2027-01-13

Last Updated

2025-12-18

Healthy Volunteers

Conditions

Solid Tumors Advanced Solid Tumors Metastatic Solid Tumors

Interventions

DRUG

INCA33890

INCA33890 will be administered at protocol defined dose.

DRUG

bevacizumab

Bevacizumab will be administered at protocol defined dose.

DRUG

FOLFIRI

FOLFIRI will be administered at protocol defined dose.

DRUG

FOLFOX

FOLFOX will be administered at protocol defined dose.

DRUG

Cetuximab

Cetuximab will be administered at protocol defined dose.

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.

Locations (36)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Cancer and Hematology Centers of Western Michigan-Start Midwest

Grand Rapids, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Nyu Langone Health - Long Island Hospital

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lifespan Cancer Research Institute

Providence, Rhode Island, United States

University of Texas Md Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, Denmark

Herlev Og Gentofte Hospital

Herlev, Denmark

Odense University Hospital

Odense C, Denmark

Vejle Hospital

Vejle, Denmark

Centre Leon Berard

Lyon, France

Institut Gustave Roussy

Villejuif, France

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Irccs Istituto Clinico Humanitas

Rozzano, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

Kansai Medical University Hospital

Hirakata, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of Jfcr

Tokyo, Japan

Start Barcelona

Barcelona, Spain

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Fundacion Jimenez Diaz University Hospital

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Centro Integral Oncologico Clara Campal

Madrid, Spain

Istituto Oncologico Della Svizzera Italiana

Bellinzona, Switzerland

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom

Guys and St Thomas Nhs Foundation Trust

London, United Kingdom

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, United Kingdom

Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

Newcastle upon Tyne, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (36)