SMT-NK / SMT Bio - LARVOL DELTA

Safety and efficacy of allogeneic natural killer cells in combination with pembrolizumab in patients with chemotherapy-refractory biliary tract cancer: A multicenter open-label phase 1/2a trial. (ASCO 2023) - P1/2, P2b | "SMT-NKs plus pembrolizumab resulted in no severe AEs directly related to the drug combination. The combination therapy also exerted antitumor activity with improved efficacy compared to recent monotherapy with pembrolizumab in patients with advanced biliary tract cancer. A multi-center, randomized, placebo-controlled, open-label, phase 2b clinical trials to evaluate the antitumor activity of combination therapy of SMT-NKs and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer is now ongoing with the aim of enrolling 128 patients (ClinicalTrials.gov identifier: NCT05429697)."

Clinical • Combination therapy • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety and Efficacy of Allogeneic Natural Killer Cells in Combination with Pembrolizumab in Patients with Chemotherapy-Refractory Biliary Tract Cancer: A Multicenter Open-Label Phase 1/2a Trial. (PubMed, Cancers (Basel)) - "SMT-NKs plus pembrolizumab resulted in no severe AEs directly related to the drug combination. The combination therapy also exerted antitumor activity with improved efficacy compared to the recent monotherapy with pembrolizumab in patients with advanced biliary tract cancer."

Combination therapy • Journal • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2b | N=128 | Recruiting | Sponsor: SMT bio Co., Ltd.

Combination therapy • Monotherapy • New P2b trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI • PD-L1

Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: SMT bio Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Feb 2021 ➔ Jun 2021

Combination therapy • Trial completion • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6 • MSI • PD-L1