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 (Jun 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
Treatments studied
Other
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Prostate Cancer
Pancreatic Cancer
Tumor Agnostic
Non-Small Cell Lung Carcinoma
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)
Demographics
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 →Frequently asked questions
Is NCT07080242 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase inhibitor-based antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require DLL3?
Yes, DLL3 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify