A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT05836324
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
408 participants
INTERVENTIONAL
2023-07-24
2027-01-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a - Dose Escalation Monotherapy
INCA33890 will be administered at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
Part 1b-Dose Expansion Monotherapy
INCA33890 will be administered at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
Part 2a - Dose Escalation Combination Therapy - Group 1
INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
bevacizumab
Bevacizumab will be administered at protocol defined dose.
Part 2a - Dose Escalation Combination Therapy - Group 2
INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
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.
Part 2a - Dose Escalation Combination Therapy - Group 3
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
bevacizumab
Bevacizumab will be administered at protocol defined dose.
FOLFOX
FOLFOX will be administered at protocol defined dose.
Part 2a - Dose Escalation Combination Therapy - Group 4
INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
Part 2b - Dose Expansion Combination Therapy - Group 1
INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
bevacizumab
Bevacizumab will be administered at protocol defined dose.
Part 2b - Dose Expansion Combination Therapy - Group 2
INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
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.
Part 2b - Dose Expansion Combination Therapy - Group 3
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
bevacizumab
Bevacizumab will be administered at protocol defined dose.
FOLFOX
FOLFOX will be administered at protocol defined dose.
Part 2b - Dose Expansion Combination Therapy - Group 4
INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
INCA33890
INCA33890 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Nyu Langone Health - Long Island Hospital
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lifespan Cancer Research Institute
Providence, Rhode Island, United States
University of Texas Md Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, , Denmark
Herlev Og Gentofte Hospital
Herlev, , Denmark
Odense University Hospital
Odense C, , Denmark
Vejle Hospital
Vejle, , Denmark
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Centro Ricerche Cliniche Di Verona
Verona, , Italy
Kansai Medical University Hospital
Hirakata, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of Jfcr
Tokyo, , Japan
Start Barcelona
Barcelona, , Spain
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Istituto Oncologico Della Svizzera Italiana
Bellinzona, , Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, , United Kingdom
Guys and St Thomas Nhs Foundation Trust
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester, , United Kingdom
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Related Links
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A study to evaluate the safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Other Identifiers
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2022-502456-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA 33890-101
Identifier Type: -
Identifier Source: org_study_id