Overview
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
Inclusion Criteria:
- ≥18 years old
- Histologically or cytologically confirmed advanced or metastatic malignancies
- Participants must have experienced disease progression after treatment with available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
- ECOG performance status score of 0 or 1.
- Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory for Part 1b cohorts only.
- 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.
- Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.
- History of clinically significant or uncontrolled cardiac disease
- Active HBV (or at risk of activation), 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
- Participants with adequate laboratory values within the protocol defined ranges.