Recruiting NCT07195916
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INCA036873.
- Who it may be relevant to
- Registry conditions: Solid Tumors, Hematologic Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Denmark, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Overview
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Interventions
- Drug INCA036873
Intravenously (IV)
Primary outcome measures
- 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]
Secondary outcome measures (11)
- Pharmacokinetics Parameter: Cmax of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: Tmax of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: Cmin of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: AUC(0-t) of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: AUC 0-∞ of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: CL of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: Vz of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Pharmacokinetics Parameter: t1/2 of INCA036873 [Time frame: Up to approximately 2 years and 90 days]
- Objective response [Time frame: Up to approximately 2 years]
- Disease control [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) [Time frame: Up to approximately 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- City of Hope Medical Center — Duarte
- University of California San Diego Medical Center, Moores Cancer Center — La Jolla
- University of Michigan — Ann Arbor
- The University of Nebraska Medical Center — Omaha
- Memorial Sloan Kettering Cancer Center — New York
- Scri Oncology Partners — Nashville
- Vanderbilt Medical Center — Nashville
- Md Anderson Cancer Center — Houston
Australia · 4 centers
- Macquarie University Hospital — Sydney
- Princess Alexandra Hospital Australia — Woolloongabba
- Cancer Research Sa — Adelaide
- Peter Maccallum Cancer Centre-Royal Melbourne Hospital — Melbourne
Belgium · 4 centers
- Cliniques Universitaires Ucl Saint-Luc — Brussels
- Universitair Ziekenhuis Antwerpen — Edegem
- Universitair Ziekenhuis Gent (Uz Gent) — Ghent
- Universitair Ziekenhuis Leuven — Leuven
Italy · 4 centers
- Aou Policlinico S. Orsola-Malpighi — Bologna
- Fondazione Irccs Istituto Nazionale Dei Tumori — Milan
- Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore — Rome
- Centro Ricerche Cliniche Di Verona — Verona
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Rigshospitalet Uni of Hospital of Copenhagen — Copenhagen
Identifiers
NCT: NCT07195916 · INCA036873-101 · 2025-523130-11-00