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NCT05836324
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Conditions: Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 570
Sponsor: Incyte Corporation
Location: The Angeles Clinic and Research Institute Los Angeles California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT05836324). StuddyBuddy aggregates publicly available trial information.