Primary Outcome Measures
- Number of Patients who Experience Dose-Limiting Toxicity
- Number of patients who experience a treatment-related adverse event
- Objective response rate (ORR)
- Duration of response (DOR)
- Progression free survival (PFS)
- Overall survival (OS)
Secondary Outcome Measures
- Area under the plasma concentration versus time curve (AUC)
- Time to achieve maximal plasma concentration (Tmax)
- Maximum observed plasma concentration (Cmax)
- Terminal elimination half-life (t1/2)
- Apparent total plasma clearance when dosed orally (CL/F)
- Apparent volume of distribution when dosed orally (Vz/F)
Inclusion Criteria
- Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
- Unresectable or metastatic disease.
- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Exclusion Criteria
- Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
- Active brain metastases or carcinomatous meningitis.
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
- Major surgery within 4 weeks of first dose of study treatment.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- Cardiac abnormalities.
- Other protocol-defined Inclusion/Exclusion criteria apply.