BL-M17D1 / Sichuan Biokin Pharmaceutical, Systimmune - LARVOL DELTA

Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: SystImmune Inc. | N=120 ➔ 3 | Trial completion date: Dec 2027 ➔ Jan 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2027 ➔ Jan 2026; The decision is based only on the Sponsor's internal portfolio prioritization and resource management considerations and is not due to the investigational product's toxicity considerations.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bladder Cancer • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Urothelial Cancer

Phase 1 Open-Label Study BL-M17D1 w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: SystImmune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Urothelial Cancer

Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: SystImmune Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Urothelial Cancer

A Phase l study to Evaluate the safey, Tolerabity, Pharmacokinetic characteristics and Preliminany ficacy of Bl-M17D1 in paients With localy Adyanced or Metastatic (ChiCTR) - P1 | N=60 | Sponsor: hunan cancer hospital; hunan cancer hospital

New P1 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • HER-2

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M17D1 in Subjects with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: SystImmune Inc.

Metastases • New P1 trial • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors (PRNewswire) - "SystImmune, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology. The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors in the United States."

IND • New P1 trial • Oncology • Solid Tumor

BL-M17D1-101: A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

BL-M17D1-102: A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

BL-M17D1-102: A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

BL-M17D1-101: A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor