NCT06714617

Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: SystImmune Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.

Detailed description

BL-M17D1-ST-101 is a multicenter, Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M17D1 in subjects with unresectable locally advanced or metastatic HER2-expressing or HER2-mutant solid tumors. This study will be conducted in three parts (dose escalation, dose finding and dose expansion). BL-M17D1 will be administered on Day 1 and Day 8 of a continuous 21-day treatment cycle.

Conditions

• Breast Cancer Stage III
• HER2-positive Metastatic Breast Cancer
• Unresectable Breast Carcinoma
• Her2-Positive
• HER2 Gene Mutation
• Gastroesophageal-junction Cancer
• Non Small Cell Lung Cancer
• Endometrial Neoplasms
• Peritoneal Cancer
• Fallopian Tube Cancer
• Ovarian Cancer
• Urothelial Carcinoma Bladder
• Solid Tumor, Adult
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	BL-M17D1	The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks.

Timeline

• Start date: 2025-04-10
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-12-03
• Last updated: 2025-11-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study