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OncoMatch/Clinical Trials/NCT07080242

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

Official title: 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

Is NCT07080242 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies BL-M14D1 for small cell lung cancer metastatic or locally advanced.

Phase 1RecruitingSystImmune Inc.NCT07080242Data as of Oct 2026

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

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Extracted eligibility criteria

Treatments studied

Other

BL-M14D1

Cancer type

Small Cell Lung Cancer

Neuroendocrine Tumor

Prostate Cancer

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: DLL3 expression (positive)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard therapy — advanced/metastatic

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 SCLC

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.

Cannot have received: topoisomerase inhibitor-based antibody-drug conjugate

Participants who have received prior topoisomerase inhibitor-based ADC therapy

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

No serious cardiac dysfunction and left ventricular ejection fraction ≥50%

No serious cardiac dysfunction and left ventricular ejection fraction ≥50%. Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clearview Cancer Institute · Huntsville, Alabama
  • Los Alamitos Hematology/Oncology Medical Group · Glendale, California
  • MemorialCare Long Beach Medical Center · Long Beach, California
  • Valkyrie Clinical Trials · Los Angeles, California
  • UCLA · Los Angeles, California

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, topoisomerase inhibitor-based antibody-drug conjugate disqualifies patients from enrollment.

Does this trial require DLL3?

Yes, DLL3 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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