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

NCT07195916 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: INCA036873-1012025-523130-11-00
• Study Type: interventional
• Target: 280
• Locations: 5 countries
• Sites: 22

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

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

Outcome Measures

Primary Outcomes (2)

• Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

  Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

  Up to Day 28

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  Up to approximately 2 years and 90 days

Secondary Outcomes (11)

• Pharmacokinetics Parameter: Cmax of INCA036873

  Up to approximately 2 years and 90 days

• Pharmacokinetics Parameter: Tmax of INCA036873

  Up to approximately 2 years and 90 days

• Pharmacokinetics Parameter: Cmin of INCA036873

  Up to approximately 2 years and 90 days

• Pharmacokinetics Parameter: AUC(0-t) of INCA036873

  Up to approximately 2 years and 90 days

• Pharmacokinetics Parameter: AUC 0-∞ of INCA036873

  Up to approximately 2 years and 90 days

Study Arms (3)

Part 1a Dose Escalation

EXPERIMENTAL

INCA036873 will be administered at the protocol defined dose.

Drug: INCA036873

Part 1b Dose Expansion

EXPERIMENTAL

INCA036873 will be administered at the protocol defined dose.

Drug: INCA036873

Part 1c Pharmacodynamic Cohort

EXPERIMENTAL

INCA036873 will be administered at the protocol defined dose.

Drug: INCA036873

Interventions

INCA036873 DRUG

Intravenously (IV)

Part 1a Dose Escalation; Part 1b Dose Expansion; Part 1c Pharmacodynamic Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (22)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, 92037, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

The University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

NOT YET RECRUITING

Scri Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Md Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Macquarie University Hospital

Sydney, New South Wales, 02109, Australia

RECRUITING

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, 04102, Australia

RECRUITING

Cancer Research Sa

Adelaide, South Australia, 05000, Australia

RECRUITING

Peter Maccallum Cancer Centre-Royal Melbourne Hospital

Melbourne, Victoria, 03000, Australia

RECRUITING

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 02650, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 09000, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 03000, Belgium

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 08200, Denmark

NOT YET RECRUITING

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, DK-2100, Denmark

NOT YET RECRUITING

Aou Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

NOT YET RECRUITING

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168, Italy

NOT YET RECRUITING

Centro Ricerche Cliniche Di Verona

Verona, 37134, Italy

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Hematologic Neoplasms; Carcinoma, Renal Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Lymphoma, B-Cell; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Incyte Study Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): August 18, 2028
• Study Completion (Estimated): August 18, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); BE (4); DK (2); AU (4); US (8)