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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Minor Trial sites expanded: 20 → 24 locations
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Minor Site details revised at 2 of 20 sitesv6
  3. Notable Primary endpoint(s) modified
    • Eligibility criteria shortened, about 1,064 words
    • Secondary endpoints: 18 to 2
    • Study sites revised (20)
    v5
  4. Minor Study sites: 16 to 20
    • Eligibility criteria expanded, about 80 words
    • Study description shortened, about 29 words
    v4
  5. Minor Study sites: 3 to 16v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 1, 2025 to Apr 28, 2025
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07080242
Lead Sponsor SystImmune Inc.
Conditions
(from sponsor)
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer, Metastatic Neuroendocrine Prostate Cancer, Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma, Metastatic Advanced Merkel Cell Carcinoma, Locally Advanced Large Cell Neuroendocrine Carcinoma of the Lung, Locally Advanced Extrapulmonary Neuroendocrine Carcinoma, Locally Advanced Neuroendocrine Prostate Cancer +3 more
Related terms Carcinoma, Neuroendocrine
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov