Recruiting
Phase 1

INCA036873

Sponsor:

Incyte Corporation

Code:

NCT07195916

Conditions

Solid Tumors

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA036873

Study Details

Brief summary:

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

Conditions

Solid Tumors

Hematologic Malignancies

Study ID

NCT07195916

Start date

Jan 8, 2026

Status verified date

Sep, 2026

Completion date

Aug 18, 2028

Anticipated

Primary completion date

Aug 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

280 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a Dose Escalation

INCA036873 will be administered at the protocol defined dose.

experimental: Part 1b Dose Expansion

INCA036873 will be administered at the protocol defined dose.

experimental: Part 1c Pharmacodynamic Cohort

INCA036873 will be administered at the protocol defined dose.

Interventions

INCA036873

Intravenously (IV)

Primary outcome measure

  • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years and 90 days ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

University of California San Diego Medical Center, Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

The University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Scri Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Incyte Corporation

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Advanced solid tumors
  • Metastatic solid tumors
  • Clear cell renal cell carcinoma (ccRCC)
  • Diffuse large B-cell lymphoma (DLBCL)
  • High-grade B-cell lymphoma (HGBCL)
  • Peripheral T-cell lymphoma (PTCL, incl. ALCL)
  • Cutaneous T-cell lymphoma (CTCL, incl. MF and SS)
  • Non-Hodgkin lymphoma (NHL)
  • CD70
  • Bispecific antibody
  • Immunotherapy
  • T-cell engager

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.