Clinical Trials in Italy / NCT07195916
Recruiting
Phase 1
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
NCT07195916 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Solid TumorsHematologic Malignancies
Investigational drug(s) / intervention(s)
INCA036873
INCA036873: Intravenously (IV)
Study summary
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Eligibility
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 | Rome | Italy | Not Yet Recruiting |
| Centro Ricerche Cliniche Di Verona | Verona | Italy | Not Yet Recruiting |
More Incyte Corporation trials in Italy
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Active, not recruiting
Other trials for the same condition
Official registry record
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.
View NCT07195916 on ClinicalTrials.gov ↗ ← All trials in Italy