CGT6297 is an investigational mutant-selective PI3Kalpha inhibitor being studied in Phase 1 dose-escalation and signal-seeking cohorts for advanced solid tumors with PIK3CA mutations. The program includes endometrial and breast cancer cohorts and remains in early clinical development. It is not an approved marketed therapy.
Cogent Biosciences has submitted a New Drug Application for bezuclastinib to treat systemic mastocytosis caused by the KIT D816V mutation, with FDA review underway and strong analyst support.
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07383506 |
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
