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

Last updated: December 3, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Solid Tumors

Treatment

FOLFIRI

FOLFOX

Cetuximab

Clinical Study ID

NCT05836324
INCA 33890-101
2022-502456-31-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old

  • Histologically or cytologically confirmed advanced or metastatic malignancies asdefined 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, includinganti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinicalbenefit. Part 2: depending on cohort, participants may have received or not priortreatment 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

Exclusion Criteria:

  • Any known additional malignancy that is progressing or requires active treatment, orhistory 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 withcorticosteroids.

  • 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 anticoagulationtherapies within the last 3 months prior to first dose of treatment.

  • Significant concurrent, uncontrolled medical condition, eg:

  • Cardiovascular: Participants with known vasculitis, aneurisms, and othervascular 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

Total Participants: 408
Treatment Group(s): 5
Primary Treatment: FOLFIRI
Phase: 1
Study Start date:
July 24, 2023
Estimated Completion Date:
January 13, 2027

Connect with a study center

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen, 02100
    Denmark

    Site Not Available

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen 2618425, 02100
    Denmark

    Active - Recruiting

  • Herlev Og Gentofte Hospital

    Herlev, 02730
    Denmark

    Site Not Available

  • Herlev Og Gentofte Hospital

    Herlev 2620431, 02730
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense C, 05000
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense C 11746507, 05000
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle, 07100
    Denmark

    Site Not Available

  • Vejle Hospital

    Vejle 2610613, 07100
    Denmark

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

    Milano, 20133
    Italy

    Active - Recruiting

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Irccs Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37134
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona 3164527, 37134
    Italy

    Active - Recruiting

  • Kansai Medical University Hospital

    Hirakata, 573-1191
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata 1862540, 573-1191
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Jfcr

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Jfcr

    Kōtoku 2128852, 135-8550
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo 1850147, 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Jfcr

    Tokyo 1850147, 135-8550
    Japan

    Active - Recruiting

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Start Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital General Universitario Vall D Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Start Barcelona

    Barcelona 3128760, 08023
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050
    Spain

    Active - Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Istituto Oncologico Della Svizzera Italiana

    Bellinzona, 06500
    Switzerland

    Site Not Available

  • Istituto Oncologico Della Svizzera Italiana

    Bellinzona 2661567, 06500
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne 2659994, 01011
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen 2658822, 09007
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    St. Gallen, 09007
    Switzerland

    Site Not Available

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas Nhs Foundation Trust

    London 2643743, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London 2643743, W12 0HS
    United Kingdom

    Active - Recruiting

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust Uk

    Manchester 2643123, M20 4BV
    United Kingdom

    Active - Recruiting

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Active - Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • The Angeles Clinic and Research Institute

    Los Angeles 5368361, California 5332921 90025
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles 5368361, California 5332921 90067
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Cancer and Hematology Centers of Western Michigan-Start Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Cancer and Hematology Centers of Western Michigan-Start Midwest

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Nyu Langone Health - Long Island Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York 10016
    United States

    Site Not Available

  • Nyu Langone Health - Long Island Hospital

    Mineola 5127134, New York 5128638 11501
    United States

    Active - Recruiting

  • Laura and Isaac Perlmutter Cancer Center

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Lifespan Cancer Research Institute

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Lifespan Cancer Research Institute

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • University of Texas Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

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