INCA036873 for adults with advanced solid tumors and blood cancers.

A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

This trial will test whether the experimental drug INCA036873 is safe and tolerable in adults with advanced or metastatic solid tumors or certain blood cancers who have already tried standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Incyte Corporation (Industry-sponsored)
• Drugs / interventions: CAR T
• Locations: 22 sites (Duarte, California and 21 other locations)
• Trial ID: NCT07195916 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial tests INCA036873 in adults with advanced solid tumors and selected hematologic malignancies, including clear cell renal cell carcinoma, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma. Eligible participants must have measurable disease, an ECOG performance status of 0–1, available tumor tissue for central testing, and disease progression after specified prior therapies. The study will use dose-escalation cohorts to define safety and tolerability and may open expansion cohorts once a recommended dose is identified. The trial is sponsored by Incyte Corporation and is enrolling at academic centers in California and Michigan.

Who should consider this trial

Good fit: Adults (≥18) with measurable advanced ccRCC, DLBCL/HGBCL, PTCL, or CTCL who have ECOG 0–1, meet the disease-specific prior therapy requirements, and can provide tumor tissue for central testing are the intended candidates.

Not a fit: Patients with untreated or unstable central nervous system disease, recent other invasive cancers, prior CD70-targeting therapies (including CAR T), or poor performance status are unlikely to benefit from participation.

Why it matters

Potential benefit: If INCA036873 proves safe and active, it could offer a new treatment option that helps control disease or delay progression for patients with limited choices.

How similar studies have performed: Other early-phase efforts targeting CD70 and related pathways have shown preliminary activity in select cancers but overall clinical benefit remains limited and requires further study.

Eligibility criteria

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.

Where this trial is running

Duarte, California and 21 other locations

• City of Hope Medical Center — Duarte, California, United States (Recruiting)
• University of California San Diego Medical Center, Moores Cancer Center — La Jolla, California, United States (Not_yet_recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
• The University of Nebraska Medical Center — Omaha, Nebraska, United States (Not_yet_recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
• Scri Oncology Partners — Nashville, Tennessee, United States (Recruiting)
• Vanderbilt Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
• Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Macquarie University Hospital — Sydney, New South Wales, Australia (Recruiting)
• Princess Alexandra Hospital Australia — Woolloongabba, Queensland, Australia (Recruiting)
• Cancer Research Sa — Adelaide, South Australia, Australia (Recruiting)
• Peter Maccallum Cancer Centre-Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
• Cliniques Universitaires Ucl Saint-Luc — Brussels, Belgium (Not_yet_recruiting)
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium (Not_yet_recruiting)
• Universitair Ziekenhuis Gent (Uz Gent) — Ghent, Belgium (Not_yet_recruiting)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (Not_yet_recruiting)
• Aarhus University Hospital — Aarhus, Denmark (Not_yet_recruiting)
• Rigshospitalet Uni of Hospital of Copenhagen — Copenhagen, Denmark (Not_yet_recruiting)
• Aou Policlinico S. Orsola-Malpighi — Bologna, Italy (Not_yet_recruiting)
• Fondazione Irccs Istituto Nazionale Dei Tumori — Milan, Italy (Not_yet_recruiting)
• Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore — Rome, Italy (Not_yet_recruiting)
• Centro Ricerche Cliniche Di Verona — Verona, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)

Conditions Solid Tumors; Hematologic Malignancies; Advanced solid tumors; Metastatic solid tumors; Clear cell renal cell carcinoma; Diffuse large B-cell lymphoma; High-grade B-cell lymphoma; Peripheral T-cell lymphoma