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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years. - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. - diagnosed by tissue sample (biopsy-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 previous cancer treatment that works throughout the body (like chemotherapy). - Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL). - Tumor tissue available for central testing. Who Should NOT Join This Trial: - 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 weakened immune system or active autoimmune conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

INCA036873

Intravenously (IV)

Locations (20)

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