NCT06293898

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: SystImmune Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Detailed description

BL-M07D1-ST-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M07D1 in participants with HER2 expressing advanced malignant solid tumors. This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle. .

Conditions

• Endometrial Cancer
• Cervical Cancer
• Ovarian Cancer
• Urothelial Carcinoma
• Biliary Tract Cancer
• Breast Cancer
• Lung Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	BL-M07D1	Drug: BL-M07D1 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 by intravenous infusion every 3 weeks. Other Names: BL-M07D1

Timeline

• Start date: 2024-02-09
• Primary completion: 2028-12-15
• Completion: 2029-04-15
• First posted: 2024-03-05
• Last updated: 2026-03-23

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study