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Clinical Trials in France / NCT05836324
Recruiting Phase 1

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

NCT05836324 · tracked via the Priya Life Science France tracker
Phase
Phase 1
Started
2023-07-24
Last updated
2026-07-23

Condition(s) studied

Solid TumorsAdvanced Solid TumorsMetastatic Solid Tumors

Investigational drug(s) / intervention(s)

INCA33890 →bevacizumab →FOLFIRI →FOLFOX →Cetuximab →ADG126 →

INCA33890: INCA33890 will be administered at protocol defined dose.

bevacizumab: Bevacizumab will be administered at protocol defined dose.

FOLFIRI: FOLFIRI will be administered at protocol defined dose.

FOLFOX: FOLFOX will be administered at protocol defined dose.

Cetuximab: Cetuximab will be administered at protocol defined dose.

ADG126: ADG126 will be administered at protocol defined dose.

Study summary

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ≥18 years old * Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. * Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study. * ECOG performance status score of 0 or 1. * Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. * Presence of measurable disease according to RECIST v1.1. Exclusion Criteria: * Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. * Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. * Has active autoimmune disease requiring systemic immunosuppression with corticosteroids. * Brain or CNS metastases untreated or that have progressed. * History of organ transplant, including allogeneic stem cell transplantation. * History of clinically significant or uncontrolled cardiac disease. * Active HBV, active HCV, or HIV positive. * Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent). * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment * Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment. * Significant concurrent, uncontrolled medical condition, eg: * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis. * Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1. * Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
The Angeles Clinic and Research Institute Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Cancer and Hematology Centers of Western Michigan-Start Midwest Grand Rapids Michigan Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Nyu Langone Health - Long Island Hospital Mineola New York Recruiting
Laura and Isaac Perlmutter Cancer Center New York New York Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Lifespan Cancer Research Institute Providence Rhode Island Recruiting
University of Texas Md Anderson Cancer Center Houston Texas Recruiting
South Texas Accelerated Research Therapeutics San Antonio Texas Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing China Not Yet Recruiting
Peking University People'S Hospital Beijing China Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu) Hangzhou China Not Yet Recruiting
Rigshospitalet Uni of Hospital of Copenhagen Copenhagen Denmark Recruiting
Herlev Og Gentofte Hospital Herlev Denmark Recruiting
Odense University Hospital Odense C Denmark Recruiting
Vejle Hospital Vejle Denmark Recruiting
Centre Leon Berard Lyon France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy Recruiting
Irccs Istituto Clinico Humanitas Rozzano Italy Recruiting
Centro Ricerche Cliniche Di Verona Verona Italy Recruiting
Kansai Medical University Hospital Hirakata Japan Recruiting
National Cancer Center Hospital Tokyo Japan Recruiting
The Cancer Institute Hospital of Jfcr Tokyo Japan Recruiting
Start Barcelona Barcelona Spain Recruiting
Hospital General Universitario Vall D Hebron Barcelona Spain Recruiting
Fundacion Jimenez Diaz University Hospital Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Centro Integral Oncologico Clara Campal Madrid Spain Recruiting
Istituto Oncologico Della Svizzera Italiana Bellinzona Switzerland Recruiting
Centre Hospitalier Universitaire Vaudois (Chuv) Lausanne Switzerland Recruiting
Kantonsspital St. Gallen Sankt Gallen Switzerland Recruiting
Cambridge University Hospitals Nhs Foundation Trust Cambridge United Kingdom Recruiting
Guys and St Thomas Nhs Foundation Trust London United Kingdom Recruiting
Imperial College Healthcare Nhs Trust - Hammersmith Hospital London United Kingdom Recruiting
The Christie Nhs Foundation Trust Uk Manchester United Kingdom Recruiting
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust Newcastle upon Tyne United Kingdom Recruiting

On this site

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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 NCT05836324 on ClinicalTrials.gov ↗ ← All trials in France