A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

1/2

Condition

Solid Tumors

Cancer/tumors

Metastatic Cancer

Treatment

N/A

Clinical Study ID

TX225646
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.

  • Presence of measurable disease per RECIST v1.1.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.

  • Resolution of treatment-related toxicities.

  • Adequate hepatic, renal, cardiac, and hematologic function.

  • Additional cohort-specific criteria may apply.

Exclusion

Exclusion Criteria:**

  • Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
  • Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
  • Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
  • Has received prior approved radiotherapy within 14 days of study therapy.
  • Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has an active infection requiring systemic therapy.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Women who are pregnant or breastfeeding.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Connect with a study center

  • Institut Jules Bordet

    Brussels, Belgium 1200
    Belgium

    Active - Recruiting

  • Grand Hopital De Charleroi

    Charleroi, Charleroi 6000
    Belgium

    Active - Recruiting

  • UNIVERSITY COLLEGE LONDON HOSPITALS

    LONDON, LONDON NW1 2PG
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, London NW1 2PG
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, Manchester M20 4BV
    United Kingdom

    Active - Recruiting

  • UNIVERSITY OF ALABAMA AT BIRMINGHAM COMPREHENSIVE CANCER CENTER

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UNIVERSITY OF SOUTH ALABAMA MEDICAL CENTER

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Georgetown University Hospital

    Washington, District Of Columbia 20007
    United States

    Active - Recruiting

  • NORTHWEST GEORGIA ONCOLOGY CENTERS

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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