FG-M108 / FutureGen Biopharmaceutical - LARVOL DELTA

Preliminary result of a phase Ib study: Efficacy and safety of FG-M108 plus gemcitabine and nab-paclitaxel in patients with Claudin18.2-positive, locally advanced, unresectable, or metastatic pancreatic cancer. (ASCO 2025) - P1 | "The combined therapy of FG-M108 plus chemotherapy as 1L treatment for patients with CLDN18.2 positive pancreatic cancer was generally well tolerated with promising survival (PFS and OS) data especially in patients with CLDN18.2 moderate-high expression, pivatol phase III clinical study will start in 2025 Q2."

Clinical • Metastases • P1 data • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Preliminary result of a phase Ib study: Efficacy and safety of FG-M108 plus gemcitabine/nab-paclitaxel as first-line (1L) treatment in patients with Claudin18.2-positive locally advanced unresectable or metastatic (LA/m) pancreatic cancer. (ASCO-GI 2025) - P1 | "The combined therapy of FG-M108 plus chemotherapy as 1L treatment for patients with CLDN18.2 positive pancreatic cancer was well tolerated with encouraging survival especially in patients with CLDN18.2 moderate-high expression, deserving further investigation."

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

FG-M108 plus capecitabine and oxaliplatin (CAPOX) for first-line treatment of CLDN18.2+/HER2- advanced gastric/gastroesophageal junction adenocarcinoma (GC): Update results of a phase I/II trial to determine RP2D. (ASCO-GI 2025) - P1, P3 | "FG-M108 plus CAPOX had a manageable safety profile and promising antitumor activity in GC, with RP2D at 300mg/m2. A phase III trial is ongoing to confirm the efficacy of FG-M108 at 300mg/m2 plus CAPOX as first-line treatment (NCT06177041)."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

Preliminary result of a phase Ib study: Efficacy and safety of FG-M108 plus gemcitabine and nab-paclitaxel in patients with Claudin18.2 positive locally advanced unresectable or metastaticpancreatic cancer (ESMO 2024) - "FG-M108 plus gemcitabine and nab-paclitaxel as first-line treatment in patients with Claudin-18.2+ advanced PC showed promising clinical efficacy with manageable safety. the safety and efficacy, especially PFS and OS will be further evaluated."

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

A phase I/II study of FG-M108 plus capecitabine and oxaliplatin (CAPOX) as first-line (1L) treatment for patients with CLDN18.2+/HER2- advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ESMO 2024) - P1 | "FG-M108 has demonstrated superior anti-tumor activity compared with zolbetuximab and excellent safety profile in preclinical studies. This phase I/IIa study evaluated the safety and preliminary anti-tumor activity of FG-M108 300 mg/m2 Q3W plus CAPOX in patients with HER2- and CLDN18.2+ (IHC1/2/3+≥10%) advanced or metastatic G/GEJ adenocarcinoma. In advanced G/GEJ cancer patients with medium to high level of CLDN18.2 expression, FG-M108 plus CAPOX as the first-line treatment showed a manageable safety profile and improved efficacy outcomes as compared to historical CAPOX controls."

Clinical • Metastases • P1/2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2

FG-M108 plus nab-paclitaxel and gemcitabine (AG) as first-line (1L) treatment for patients with Claudin-18.2 (CLDN18.2) positive locally advanced unresectable or metastatic pancreatic cancer (PC): Preliminary results from the phase 1b study. (ASCO 2024) - P1 | "FG-M108 plus AG showed excellent safety profile and promising clinical efficacy as 1L treatment for patients with CLDN18.2+ locally advanced unresectable or metastatic PC. The safety and efficacy, especially PFS and OS, of FG-M108 plus AG treatment will be further evaluated."

Clinical • Metastases • P1 data • Anemia • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Safety and efficacy results from the phase I/IIa study of FG-M108 plus CAPOX as first-line (1L) treatment for patients with CLDN18.2+/HER2- locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. (ASCO 2024) - P3 | "FG-M108 plus CAPOX as 1L treatment for CLDN18.2+/HER2- advanced G/GEJ cancer showed good tolerability and improved efficacy compared to historical CAPOX control, with an apparent trend of better efficacy with higher CLDN18.2 expression. Based on these results, pivotal phase 3 study of FG-M108 plus CAPOX versus CAPOX as 1L treatment of locally advanced unresectable or metastatic G/GEJ adenocarcinoma expressing medium/high CLDN18.2 has been initiated and is ongoing."

Clinical • Metastases • P1/2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Thrombocytopenia • CLDN18 • HER-2

M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China (clinicaltrials.gov) - P1 | N=152 | Recruiting | Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Jul 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China (clinicaltrials.gov) - P1; N=152; Recruiting; Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd; Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China (clinicaltrials.gov) - P1; N=152; Not yet recruiting; Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd

Clinical • New P1 trial • Oncology • Solid Tumor