BL-M05D1 / Sichuan Biokin Pharmaceutical, Systimmune - LARVOL DELTA

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: SystImmune Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Biliary Tract Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • CLDN18 • FGFR2 • HER-2 • IDH1 • KRAS • MSI • NTRK • PD-L1

A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment (clinicaltrials.gov) - P3 | N=438 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

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

A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment (clinicaltrials.gov) - P3 | N=438 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

SystImmune, Inc…announced the presentation of data on iza-bren (izalontamab brengitecan), BL-M14D1, T-Bren (BL-M07D1), and BL-M05D1, four distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting taking place May 29 – June 2 in Chicago. (PRNewswire)

P1 data • P2 data • P3 data • Esophageal Squamous Cell Carcinoma • Neuroendocrine Carcinoma • Ovarian Cancer • Small Cell Lung Cancer • Triple Negative Breast Cancer

Phase I study of BL-M05D1, a novel Claudin18.2-directed antibody-drug conjugate (ADC), in patients with locally advanced or metastatic Claudin18.2–expressing solid tumors. (ASCO 2026) - P1 | "BL-M05D1 has demonstrated a promising antitumor activity with a tolerable safety profile in pts with pretreated Claudin18.2-positive PanC, GC, and BTC. 4.0mg/kg D1 Q3W was chosen as RP2D. The data support further development of BL-M05D1 in Claudin18.2-positive PanC, GC, and BTC."

ADC • Clinical • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Febrile Neutropenia • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • CLDN18

BL-M05D1, a novel claudin 18.2-targeting ADC, demonstrates specific potent anti-tumor efficacy in preclinical evaluation (AACR 2024) - "In summary, these studies suggest BL-M05D1, a novel Claudin 18.2-targeting ADC, is potentially efficacious in the treatment of Claudin 18.2-expressing carcinomas. The clinical phase I is being undertaken to evaluate safety, dosing and observations of preliminary signs of efficacy."

ADC • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • CTSB

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: SystImmune Inc. | N=120 ➔ 160

Enrollment change • Biliary Cancer • Biliary Tract Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • CLDN18 • FGFR2 • HER-2 • IDH1 • KRAS • MSI • NTRK • PD-L1

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: SystImmune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: SystImmune Inc.

New P1 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

BL-M05D1-101: A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor