A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Phase 1 – testing safety in a small group of people
Conditions:
Solid Tumors
Hematologic Malignancies
Sponsor: Incyte Corporation
trial.available_in:
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Overview
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Who can participate
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.
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