NCT05836324Recruiting
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Countries
- Switzerland, France, Italy, United States, China, Denmark, Japan, Spain, United Kingdom
- Sponsor
- Incyte Corporation(Industry)
- Protocol no.
- INCA 33890-101
- Conditions
- Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
- Interventions
- Drug
Treatments studied
- INCA33890
- bevacizumab
- FOLFIRI
- FOLFOX
- Cetuximab
- ADG126
Locations · 36
- Bellinzona, SwitzerlandIstituto Oncologico Della Svizzera ItalianaRecruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois (Chuv)Recruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Lyon, FranceCentre Leon BerardRecruiting at this site
- Villejuif, FranceInstitut Gustave RoussyRecruiting at this site
- Milan, ItalyFondazione Irccs Istituto Nazionale Dei TumoriRecruiting at this site
- Rozzano, ItalyIrccs Istituto Clinico HumanitasRecruiting at this site
- Verona, ItalyCentro Ricerche Cliniche Di VeronaRecruiting at this site
- Los Angeles, United StatesThe Angeles Clinic and Research InstituteRecruiting at this site
- Los Angeles, United StatesValkyrie Clinical TrialsRecruiting at this site
- Boston, United StatesDana Farber Cancer InstituteRecruiting at this site
- Grand Rapids, United StatesCancer and Hematology Centers of Western Michigan-Start MidwestRecruiting at this site
- Hackensack, United StatesHackensack University Medical CenterRecruiting at this site
- Mineola, United StatesNyu Langone Health - Long Island HospitalRecruiting at this site
- New York, United StatesLaura and Isaac Perlmutter Cancer CenterRecruiting at this site
- Philadelphia, United StatesUniversity of PennsylvaniaRecruiting at this site
- Providence, United StatesLifespan Cancer Research InstituteRecruiting at this site
- Houston, United StatesUniversity of Texas Md Anderson Cancer CenterRecruiting at this site
- San Antonio, United StatesSouth Texas Accelerated Research TherapeuticsRecruiting at this site
- Copenhagen, DenmarkRigshospitalet Uni of Hospital of CopenhagenRecruiting at this site
- Herlev, DenmarkHerlev Og Gentofte HospitalRecruiting at this site
- Odense C, DenmarkOdense University HospitalRecruiting at this site
- Vejle, DenmarkVejle HospitalRecruiting at this site
- Hirakata, JapanKansai Medical University HospitalRecruiting at this site
- Tokyo, JapanNational Cancer Center HospitalRecruiting at this site
- Tokyo, JapanThe Cancer Institute Hospital of JfcrRecruiting at this site
- Barcelona, SpainStart BarcelonaRecruiting at this site
- Barcelona, SpainHospital General Universitario Vall D HebronRecruiting at this site
- Madrid, SpainFundacion Jimenez Diaz University HospitalRecruiting at this site
- Madrid, SpainHospital Universitario 12 de OctubreRecruiting at this site
In total, worldwide, 36 of the 39 sites listed in the registry are recruiting; the other 3 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: July 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 6 more locations
Other identifiers
- 2022-502456-31-00 · other registry
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.