A Phase I 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

Study Identifier:
BL-M14D1-ST-101
CT.gov Identifier:
NCT07080242
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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 Tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Small Cell Lung
Neuroendocrine
Prostate
Metastatic Cancer
Merkel Cell Carcinoma
Large Cell Neuroendocrine Carcinoma of the Lung
Extrapulmonary Neuroendocrine Carcinoma
Gastroenteropancreatic Neuroendocrine
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Experimental BL-M14D1 administered Day 1 per cycle
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Drug: Intervention/Treatment
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • 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.
  • At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
  • Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy
  • No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
  • Adequate organ function
Exclusion criteria
  • 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.
  • Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable.
  • Participated in another clinical trial within 4 weeks prior to first dose of study treatment
  • Participants who are pregnant or breastfeeding, or planning to become pregnant during the study
  • Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Small Cell Lung
Neuroendocrine
Prostate
Metastatic Cancer
Merkel Cell Carcinoma
Large Cell Neuroendocrine Carcinoma of the Lung
Extrapulmonary Neuroendocrine Carcinoma
Gastroenteropancreatic Neuroendocrine
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Small Cell Lung
Neuroendocrine
Prostate
Metastatic Cancer
Merkel Cell Carcinoma
Large Cell Neuroendocrine Carcinoma of the Lung
Extrapulmonary Neuroendocrine Carcinoma
Gastroenteropancreatic Neuroendocrine