A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) — Up to Day 28 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to approximately 2 years and 90 days 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.
Trial sites (22)
Facility
City
Region
Status
City of Hope Medical Center
Duarte
California
Recruiting
University of California San Diego Medical Center, Moores Cancer Center
La Jolla
California
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
The University of Nebraska Medical Center
Omaha
Nebraska
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Scri Oncology Partners
Nashville
Tennessee
Recruiting
Vanderbilt Medical Center
Nashville
Tennessee
Not Yet Recruiting
Md Anderson Cancer Center
Houston
Texas
Recruiting
Macquarie University Hospital
Sydney
New South Wales
Recruiting
Princess Alexandra Hospital Australia
Woolloongabba
Queensland
Recruiting
Cancer Research Sa
Adelaide
South Australia
Recruiting
Peter Maccallum Cancer Centre-Royal Melbourne Hospital
Melbourne
Victoria
Recruiting
Cliniques Universitaires Ucl Saint-Luc
Brussels
Belgium
Recruiting
Universitair Ziekenhuis Antwerpen
Edegem
Belgium
Recruiting
Universitair Ziekenhuis Gent (Uz Gent)
Ghent
Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven
Belgium
Recruiting
Aarhus University Hospital
Aarhus
Denmark
Not Yet Recruiting
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen
Denmark
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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