NCT07080242

Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: SystImmune Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Detailed description

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Conditions

• Small Cell Lung Cancer Metastatic or Locally Advanced
• Neuroendocrine Cancer
• Metastatic or Locally Advanced Neuroendocrine Prostate Cancer
• Metastatic or Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
• Metastatic or Locally Advanced Merkel Cell Carcinoma
• Locally Advanced or Metastatic Large Cell Neuroendocrine Carcinoma of the Lung
• Metastatic or Locally Advanced Extrapulmonary Neuroendocrine Carcinoma
• Poorly Differentiated and/or High Grade Neuroendocrine Neoplasms With Evidence of DLL3 Expression

Interventions

Type	Name	Description
DRUG	BL-M14D1	BL-M14D1 will be administered on D1 every 3 weeks.

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-23
• Last updated: 2026-02-09

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study