This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
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Dose-limiting Toxicities (DLTs) of IDE397
Timeframe: 21 days following the first dose of IDE397
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Timeframe: 21 - 28 days following the first dose of IDE397
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Timeframe: Approximately 2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
Timeframe: Approximately 2 years
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Timeframe: Approximately 2 years