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A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Trial Status: active
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05836324.
