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

Incyte

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors; Hematologic Malignancies

Treatments: Drug: INCA036873

Study type: Interventional

Funder types: Industry

Identifiers

NCT07195916

INCA036873-101

2025-523130-11-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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280 participants in 3 patient groups

Part 1a Dose Escalation

Experimental group

Description:

INCA036873 will be administered at the protocol defined dose.

Treatment:

Drug: INCA036873

Part 1b Dose Expansion

Experimental group

Description:

INCA036873 will be administered at the protocol defined dose.

Treatment:

Drug: INCA036873

Part 1c Pharmacodynamic Cohort

Experimental group

Description:

INCA036873 will be administered at the protocol defined dose.

Treatment:

Drug: INCA036873