Status:
NOT_YET_RECRUITING
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2028
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT07195916
Start Date
December 31 2025
End Date
August 18 2028
Last Update
October 15 2025
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