BGB-53038 / BeOne Medicines - LARVOL DELTA

BGB-53038-101: A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification (clinicaltrials.gov) - P1 | N=47 | Terminated | Sponsor: BeOne Medicines | N=514 ➔ 47 | Trial completion date: Dec 2026 ➔ Apr 2026 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2026 ➔ Apr 2026; The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape.

Enrollment change • First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

BeOne shelves 5 cancer programs… (FierceBiotech) - "Four of the five cancer assets have been discontinued entirely, BeOne announced in its May 6 earnings presentation (PDF). These are the EGFR-targeting BG-60366, which was in development for lung cancer; a pan-KRAS inhibitor called BGB-53038 for lung and gastrointestinal tumors; MAT2A inhibitor BG-89894 for lung and solid tumors; and CDK2 inhibitor BG-68501, for breast and solid tumors....A study of the CCR8 antibody BGB-A3055 in solid tumors has also been terminated, but this asset has not been fully discontinued, a BeOne spokesperson confirmed to Fierce Biotech."

Discontinued • Trial termination • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer

BGB-53038-101: A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification (clinicaltrials.gov) - P1 | N=514 | Recruiting | Sponsor: BeiGene | N=177 ➔ 514

Enrollment change • Monotherapy • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

BeiGene Announces Fourth Quarter and Full Year 2024 Financial Results and Business Update (Businesswire) - "Anticipate...internal proof-of-concept data for BG-60366 (EGFR CDAC), BGB-53038 (panKRAS inhibitor), BG-C137 (FGFR2b ADC), BGB-C354 (B7H3 ADC), and BG-C477 (CEA ADC) in the second half of 2025."

P1 data • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-53038-101: A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification (clinicaltrials.gov) - P1 | N=177 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

BeiGene Announces Third Quarter 2024 Financial Results and Corporate Updates (Businesswire) - "BGB-16673 (BTK CDAC): Anticipate initiation of Phase 3 trial in R/R CLL in the first half of 2025; NMEs on track to enter the clinic in the fourth quarter of 2024...BGB-53038 (PanKRAS inhibitor): highly potent and selective with broad activity against KRAS mutations in multiple tumor types; limits toxicity by sparing other RAS proteins and BG-C137 (FGFR2b ADC): potential first-in-class ADC for a validated target in upper gastrointestinal and breast cancers; potential superior efficacy compared to leading monoclonal antibody in both high- and medium-expression models."

New P3 trial • New trial • Breast Cancer • Chronic Lymphocytic Leukemia • Gastrointestinal Cancer

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplification (clinicaltrials.gov) - P1 | N=177 | Not yet recruiting | Sponsor: BeiGene

Metastases • Monotherapy • New P1 trial • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor