M3T01 / Providence Health & Services, BlueSphere Bio - LARVOL DELTA

A first-in-human phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of the novel fas ligand (FasL) inhibitor M3T01 in adults with advanced solid tumors. (ASCO 2026) - P1 | "This is an ongoing first-in-human phase I clinical trial (NCT06719362) evaluating the safety, tolerability and preliminary antitumor efficacy of M3T01 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors. Monotherapy cohorts 1-4 (100 to 600 mg) have been completed without DLT. After completion of the dose escalation portion of the trial, dose expansion cohorts will open to evaluate M3T01 in combination with standard systemic therapies in the treatment of patients with glioblastoma, gastric/esophageal adenocarcinoma, and head and neck squamous cell carcinoma."

Clinical • First-in-human • Metastases • P1 data • Brain Cancer • Esophageal Adenocarcinoma • Glioblastoma • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • FAS • FASLG

Interim results of a phase I clinical trial evaluating Fas ligand (FasL) blocking antibody M3T01 in adults with advanced treatment-refractory solid tumors (AACR 2026) - P1 | "M3T01 is being evaluated in an ongoing first-in-human phase I clinical trial (NCT06719362).MethodsDose escalation (3 + 3 design) of M3T01 as monotherapy (cohorts 1-5) and in combination with pembrolizumab (cohorts 6-8) is ongoing. Preliminary signals of antitumor efficacy with M3T01 as monotherapy have been observed. These findings support the ongoing clinical development of this potent FasL inhibitor."

Clinical • First-in-human • Metastases • P1 data • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CD4 • CD8 • FASLG