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RecruitingInterventionalPhase 1

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

NCT ID: NCT07195916Sponsor: Incyte CorporationLast updated: 2026-05-04

Summary

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

Arms & interventions

  • DrugINCA036873

    Intravenously (IV)

Outcome measures

Primary

  • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

    Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

    Time frame: Up to Day 28

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Time frame: Up to approximately 2 years and 90 days

Secondary

  • Pharmacokinetics Parameter: Cmax of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: Tmax of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: Cmin of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: AUC(0-t) of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: AUC 0-∞ of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: CL of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: Vz of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Pharmacokinetics Parameter: t1/2 of INCA036873

    Time frame: Up to approximately 2 years and 90 days

  • Objective response

    Time frame: Up to approximately 2 years

  • Disease control

    Time frame: Up to approximately 2 years

  • Duration of Response (DOR)

    Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 Criteria: * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study locations (8)

City of Hope Medical Center

Duarte, California, 91010

Recruiting

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, 92037

Not Yet Recruiting

University of Michigan

Ann Arbor, Michigan, 48109

Not Yet Recruiting

The University of Nebraska Medical Center

Omaha, Nebraska, 68198

Not Yet Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Not Yet Recruiting

Scri Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Vanderbilt Medical Center

Nashville, Tennessee, 37232

Not Yet Recruiting

Md Anderson Cancer Center

Houston, Texas, 77030

Recruiting