TSN1611 / Tyligand Bioscience - LARVOL DELTA

Efficacy and Safety of TSN1611 plus Cetuximab in Patients with KRAS G12D Mutant Advanced Solid Tumors (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor • KRAS

A phase 1/2 study of TSN1611, a highly selective oral KRAS G12D inhibitor, in solid tumors: Efficacy and safety in KRAS G12D–mutated NSCLC patients. (ASCO 2026) - P1/2 | "TSN1611 demonstrated a favorable safety profile and clinically meaningful antitumor activity in pts with KRAS G12D mutated NSCLC. Further development of TSN1611 as monotherapy and in combination regimens is ongoing."

Clinical • IO biomarker • P1/2 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Solid Tumor • KRAS

Updated results of the phase 1/2 study of TSN1611, a highly selective KRAS G12D inhibitor, in patients with advanced solid tumors. (ASCO-GI 2026) - P1/2 | "TSN1611 demonstrated promising clinical efficacy in pts with KRAS G12D mutant tumors, with a well-tolerated safety profile. These results support further evaluation of TSN1611 as a monotherapy and in combination therapies in KRAS G12D mutant tumors."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Tyligand Bioscience (Shanghai) Limited

Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Preclinical studies of TSN1611, a potent, selective, and orally bioavailable KRASG12D inhibitor (AACR 2024) - "TSN1611 is a selective KRASG12D inhibitor. It exhibited excellent selectivity and activity both in vitro and in vivo; it demonstrated favorable physicochemical properties, oral PK profiles, and brain penetration potential; it also showed acceptable margins of safety. The preclinical data supports further development."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • HRAS • KRAS • NRAS

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=440 | Recruiting | Sponsor: Tyligand Pharmaceuticals (Suzhou) Limited | N=150 ➔ 440

Enrollment change • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

The first-in-human phase 1/2 study of TSN1611, a highly selective KRAS G12D inhibitor, in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "TSN1611 was well tolerated, demonstrating acceptable PK characteristics as predicted, with preliminary tumor shrinkage observed in pts with refractory KRAS G12D mutant tumors. Phase 1b/2 studies are planned to evaluate TSN1611 both as a monotherapy and in combination with standard of care and/or novel agents treating cancer."

Clinical • Metastases • P1/2 data • Ampulla of Vater Carcinoma • Colorectal Cancer • Fatigue • Gallbladder Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Tyligand Bioscience Announces First Patient Dosed in Phase 1/2 Clinical Trial of TSN1611, a Selective and Orally Bioavailable KRAS G12D Inhibitor (PRNewswire) - "Tyligand Bioscience...announced that the first patient had been dosed in the Phase 1/2 trial of TSN1611 for the treatment of KRAS G12D mutant solid tumors in the United States....Patient recruitment is currently underway in the United States, with plans to initiate in China in the coming months."

Trial status • Solid Tumor