OncoMatch/Clinical Trials/NCT07080242
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Is NCT07080242 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M14D1 for small cell lung cancer metastatic or locally advanced.
Treatment: BL-M14D1 — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Prostate Cancer
Tumor Agnostic
Biomarker criteria
Required: DLL3 expression (evidence of DLL3 expression)
other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression
Disease stage
Required: Stage III, IV
Grade: poorly differentiated and/or high grade (for some cohorts)
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy — advanced/metastatic
who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment
Must have received: platinum-based chemotherapy — advanced/metastatic
For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting
Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate
No prior topoisomerase inhibitor-based ADC therapy is permitted
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hb) ≥9.0 g/dL (no blood/platelet transfusion, EPO, hematopoiesis agents, or G-CSF allowed 1 week prior to screening)
Kidney function
Creatinine clearance ≥60 mL/minute (Cockcroft-Gault equation) or eGFR ≥60 mL/min/1.73 m2 (CKD-EPI equation)
Liver function
Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for participants with liver metastasis at baseline), AST and ALT without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN. For participants with Gilbert's syndrome, TBIL ≤3.0×ULN in the absence of liver metastases.
Cardiac function
No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
Adequate organ function, defined as: Marrow function: ANC ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hb) ≥9.0 g/dL (no blood/platelet transfusion, EPO, hematopoiesis agents, or G-CSF allowed 1 week prior to screening); Hepatic function: TBIL ≤1.5×ULN (≤3×ULN for participants with liver metastasis at baseline), AST and ALT without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN. For participants with Gilbert's syndrome, TBIL ≤3.0×ULN in the absence of liver metastases; Renal function: Creatinine clearance ≥60 mL/minute (Cockcroft-Gault equation) or eGFR ≥60 mL/min/1.73 m2 (CKD-EPI equation); Cardiac: No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Valkyrie Clinical Trials · Los Angeles, California
- UCLA · Los Angeles, California
- UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center) · San Francisco, California
- University of Colorado - Anschutz Cancer Pavilion · Aurora, Colorado
- Yale Cancer Center · New Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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