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New treatment option for Small Cell Lung Cancer Metastatic or Locally Advanced
Official title Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT07080242
What this study is testing
What is BL-M14D1?
BL-M14D1 is an investigational medicine, being studied as a potential treatment for small cell lung cancer metastatic or locally advanced.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly...
- 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
You likely can't join if
- Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor...
- 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...
- Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma...
- Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with...
- Participated in another clinical trial within 4 weeks prior to first dose of study treatment
See the full eligibility criteria
- Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.