RecruitingPhase 1NCT07195916

A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies


Sponsor

Incyte Corporation

Enrollment

280 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.


Eligibility

Min Age: 18 Years

Inclusion Criteria14

  • Age ≥18 years.
  • ECOG performance status of 0 or 1.
  • Histologically confirmed:
  • Clear cell renal cell carcinoma (ccRCC).
  • Diffuse large B-cell lymphoma (DLBCL, NOS).
  • High-grade B-cell lymphoma (HGBCL).
  • Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).
  • Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0/B1 blood involvement).
  • Disease progression, relapse, or refractory to prior therapy:
  • ccRCC: ≥1 prior line incl. ICI + TKI.
  • DLBCL/HGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.
  • PTCL/CTCL: ≥1 prior systemic therapy.
  • Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL).
  • Tumor tissue available for central testing.

Exclusion Criteria8

  • Untreated or progressive CNS disease unless previously treated and stable.
  • Other active invasive malignancy within 2 years (except certain low-risk cancers).
  • Prior CD70-targeting therapy, including CAR T.
  • ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.
  • Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).
  • Primary immunodeficiency or active autoimmune disease requiring immunosuppression.
  • Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception.

Interventions

DRUGINCA036873

Intravenously (IV)


Locations(22)

City of Hope Medical Center

Duarte, California, United States

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, United States

University of Michigan

Ann Arbor, Michigan, United States

The University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Scri Oncology Partners

Nashville, Tennessee, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Macquarie University Hospital

Sydney, New South Wales, Australia

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, Australia

Cancer Research Sa

Adelaide, South Australia, Australia

Peter Maccallum Cancer Centre-Royal Melbourne Hospital

Melbourne, Victoria, Australia

Cliniques Universitaires Ucl Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, Denmark

Aou Policlinico S. Orsola-Malpighi

Bologna, Italy

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

View Full Details on ClinicalTrials.gov

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NCT07195916


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