NCT05983432

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 470 (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-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.

Detailed description

BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with metastatic or unresectable NSCLC and Other Solid Tumors. This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. Each Cohort has different dose groups.

Conditions

• Non Small Cell Lung Cancer
• Lung Cancer
• Breast Cancer
• Esophageal Cancer
• Small Cell Lung Cancer
• Nasopharyngeal Cancer
• Head and Neck Squamous Cell Carcinoma
• Prostate Adenocarcinoma
• Ovarian Cancer
• Endometrial Cancer
• Cervical Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen

Timeline

• Start date: 2023-08-08
• Primary completion: 2026-12-31
• Completion: 2028-03-21
• First posted: 2023-08-09
• Last updated: 2026-01-29

Locations

39 sites across 5 countries: United States, France, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study