About this trial

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

Qualifiers

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 Subgroup): participants will be eligible based on documented positive DLL3 expression.

Disqualifiers

Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.

Participants who have received prior topoisomerase inhibitor-based ADC therapy

Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years

Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc.

Trial design

Treatments tested in this trial

  • BL-M14D1

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

20
Alabama
Clearview Cancer Institute35805, Huntsville United States
California
UCLA90095, Los Angeles United States
Valkyrie Clinical Trials90067, Los Angeles United States
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)94158, San Francisco United States

Sponsors and collaborators

SystImmune Inc.

Lead sponsor