RecruitingRecruiting
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
NCT07195916 · Incyte Corporation
In plain English
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Official title
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
About this study
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
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.
Study design
Enrollment target: 280 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-08
Estimated completion: 2028-08-18
Last updated: 2026-05-04
Interventions
Drug: INCA036873
Primary outcomes
- • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) (Up to Day 28)
- • Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to approximately 2 years and 90 days)
Sponsor
Incyte Corporation · industry
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorIncyte Study Monitor · study_director, Incyte Corporation
All locations (22)
City of Hope Medical CenterRecruiting
Duarte, California, United States
University of California San Diego Medical Center, Moores Cancer CenterNot Yet Recruiting
La Jolla, California, United States
University of MichiganNot Yet Recruiting
Ann Arbor, Michigan, United States
The University of Nebraska Medical CenterNot Yet Recruiting
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer CenterNot Yet Recruiting
New York, New York, United States
Scri Oncology PartnersRecruiting
Nashville, Tennessee, United States
Vanderbilt Medical CenterNot Yet Recruiting
Nashville, Tennessee, United States
Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Macquarie University HospitalRecruiting
Sydney, New South Wales, Australia
Princess Alexandra Hospital AustraliaRecruiting
Woolloongabba, Queensland, Australia
Cancer Research SaRecruiting
Adelaide, South Australia, Australia
Peter Maccallum Cancer Centre-Royal Melbourne HospitalRecruiting
Melbourne, Victoria, Australia
Cliniques Universitaires Ucl Saint-LucNot Yet Recruiting
Brussels, Belgium
Universitair Ziekenhuis AntwerpenNot Yet Recruiting
Edegem, Belgium
Universitair Ziekenhuis Gent (Uz Gent)Not Yet Recruiting
Ghent, Belgium
Universitair Ziekenhuis LeuvenNot Yet Recruiting
Leuven, Belgium
Aarhus University HospitalNot Yet Recruiting
Aarhus, Denmark
Rigshospitalet Uni of Hospital of CopenhagenNot Yet Recruiting
Copenhagen, Denmark
Aou Policlinico S. Orsola-MalpighiNot Yet Recruiting
Bologna, Italy
Fondazione Irccs Istituto Nazionale Dei TumoriNot Yet Recruiting
Milan, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro CuoreNot Yet Recruiting
Rome, Italy
Centro Ricerche Cliniche Di VeronaNot Yet Recruiting
Verona, Italy