KQB548 / Kumquat Biosci, Bayer - LARVOL DELTA

23111 & 23111-1: A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation (clinicaltrialsregister.eu) - P1 | N=35 | Not yet recruiting | Sponsor: Bayer Consumer Care AG

New P1 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Bayer

Monotherapy • New P1 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Bayer and Kumquat Biosciences…announced today the initiation of a Phase I clinical trial with KQB548 (BAY 3771249), an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer (Bayer Press Release) - "First patients enrolled in Phase I trial with KQB548 (BAY 3771249)....The first-in-human, dose-escalation study (NCT07207707) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a monotherapy in patients with KRAS G12D mutated tumors."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Kumquat Biosciences Inc.

New P1 trial • Oncology • Solid Tumor • KRAS

Bayer and Kumquat Biosciences Enter Global Exclusive License and Collaboration in Precision Oncology (Businesswire) - "Under the agreement, Kumquat is responsible for the initiation and completion of the Phase Ia study, while Bayer will complete development and commercial activities. Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025. Under the terms of the agreement, Kumquat will receive up to $1.3 billion..."

IND • Licensing / partnership • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer