BAY 3498264 / Bayer - LARVOL DELTA

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Bayer | Trial primary completion date: Jan 2027 ➔ Apr 2027

First-in-human • Trial primary completion date • Oncology • Solid Tumor • KRAS

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Bayer | Trial completion date: Mar 2028 ➔ May 2027 | Trial primary completion date: Jul 2027 ➔ Jan 2027

First-in-human • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • KRAS

Discovery and characterization of BAY 3498264: a small molecule inhibitor targeting the RAS-SOS1 interaction (AACR 2025) - P1 | "Recent regulatory approvals of KRAS G12C selective inhibitors (KRAS G12Cis) including sotorasib and adagrasib have offered clinical advances to patients with cancer harboring the KRAS G12C mutation. Our findings support the clinical exploration of BAY 3498264 in combination with KRAS G12Cis, and other therapies targeting the MAPK pathway, potentially offering a more durable blockage of the pathway and greater benefit for patients. BAY 3498264 is now in the early stages of a novel phase I study (NCT06659341)."

Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Bayer | Trial completion date: Nov 2027 ➔ Mar 2028 | Trial primary completion date: Jan 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Bayer starts Phase I study with SOS1 inhibitor in patients with advanced KRAS-mutated tumors (Bayer Press Release) - "Bayer announced today initiation of a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor. The open-label, first-in-human, dose escalation study (NCT06659341) will evaluate the safety, tolerability and preliminary efficacy of BAY3498264 as a combination therapy in patients with advanced KRAS G12C-mutated solid tumors."

Trial status • Solid Tumor

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor