This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.
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Dose limiting toxicities (DLTs)
Timeframe: Through cycle 1 (each cycle is 28 days)
Total number of adverse events (AEs)
Timeframe: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Total number of serious adverse events (SAEs)
Timeframe: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Objective response rate (ORR)
Timeframe: Through the end of the study (approximately 5 years)
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department