CGT-6297 / Cogent Biosci - LARVOL DELTA

A PHASE 1 STUDY OF A MUTANT -SELECTIVE INHIBITOR, CGT6297, IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING PIK3CA MUTATIONS (IGCS 2026) - P1 | "Patients (N=~50) will be administe red oral CGT6297 daily in 28 -day cycles. Current Status & Future Directions: This study is currently enrolling at select sites in the United States."

Clinical • Metastases • P1 data • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Cogent Biosciences, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2026 ➔ Jun 2026

Enrollment open • Trial initiation date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A phase I study of a mutant-selective inhibitor, CGT6297, in patients with advanced solid tumors harboring PIK3CA mutations (ESMO-BC 2026) - "In phase 1b, the antitumor activity of CGT6297 will be assessed in each cohort by overall objective response rate. This study of CGT6297 is now enrolling at select sites in the United States."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Preclinical characterization of CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor (AACR 2025) - "The approved PI3Kα inhibitor, alpelisib, shows promise for this targeted class of agents with improvements in progression-free survival in ER+/Her2- breast cancer patients in combination with fulvestrant. A PI3K mutant inhibitor that spares WT PI3K is predicted to be better tolerated, require fewer dosing modifications, and therefore, have the potential to provide improved clinical benefit. Herein, we present the preclinical characterization of CGT6297, a wild type sparing PI3Kα H1047R inhibitor."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones… (GlobeNewswire) - "Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor; Present clinical data on CGT4859, Cogent’s selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3; Complete dose escalation for both CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent’s selective PI3Kα inhibitor."

IND • JAK2V617F • P1/2 data • Trial status • Breast Cancer • Cholangiocarcinoma • Lung Cancer

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Cogent Biosciences, Inc.

New P1 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Preclinical characterization of CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor (GlobeNewswire) - "In the poster being presented today, Cogent’s preclinical candidate CGT6297 demonstrates broad cellular panel profiling across multiple resistant and mutated cell lines, including, for the first time, efficacy against PI3K helical mutations. The poster also showcases the activity of CGT6297 in both ST1056 (H1047R mutant) and MCF-7 (E545K mutant) breast cancer TGI models."

Preclinical • Breast Cancer

Cogent Biosciences Announces Multiple Poster Presentations at 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Cogent Biosciences...announced four preclinical poster presentations at the upcoming 2025 AACR Annual Meeting being held in Chicago, IL April 25-30, 2025."

Preclinical • Solid Tumor

Projected Near-Term Milestones (GlobeNewswire) - "Enroll patients in the ongoing Phase 1 trial with CGT4859, a reversible, selective FGFR2 inhibitor in patients with documented FGFR mutations, including advanced cholangiocarcinoma. The trial is designed to explore the safety, tolerability and clinical activity of escalating doses of CGT4859 with a goal of selecting an active and well-tolerated dose for further clinical investigation....Submit an IND application in 2025 for CGT4255, a potent, selective ErbB2 inhibitor, highlighted by potential best-in-class brain-penetrant properties; Submit an IND application in 2025 for CGT6297, a potent allosteric inhibitor of PI3Kα, with 25-fold selectivity over PI3Kα WT."

Enrollment status • IND • Cholangiocarcinoma • Oncology • Solid Tumor

Preclinical Characterization of a Novel PI3Kα H1047R Mutant Selective Inhibitor (GlobeNewswire) - "Preclinical data from...newly announced H1047R mutant-selective PI3Kα clinical candidate will be presented...at the 2024 EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics....Poster Number: PB133:...The poster presented today highlights Cogent’s clinical candidate CGT6297, a potent allosteric inhibitor of PI3K, with 25-fold selectivity over PI3Kα WT. CGT6297 has high oral bioavailability and low clearance across species, providing robust inhibition of downstream signaling and efficacy in animal models. Importantly, when compared to a clinically relevant dose of a currently approved therapy in a mouse tumor model, CGT6297 demonstrated superior efficacy with no increase in insulin. IND-enabling studies are expected to be initiated in 2025."

Preclinical • Solid Tumor