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Recruiting Phase 1 NCT07080242

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

Trial Parameters

Condition Small Cell Lung Cancer Metastatic or Locally Advanced
Sponsor SystImmune Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2025-04-28
Completion 2027-12-31
Interventions
BL-M14D1

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. Signed the informed consent form voluntarily and agreed to follow the trial requirements 2. Age ≥18 years 3. Participant weighs more than 40 kg 4. Life expectancy of ≥3 months 5. Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting. No prior topoisomerase inhibitor-based ADC therapy is permitted. In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgr

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