Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Purpose
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
Conditions
- Small Cell Lung Cancer Metastatic or Locally Advanced
- Neuroendocrine Cancer
- Metastatic Neuroendocrine Prostate Cancer
- Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
- Metastatic Advanced Merkel Cell Carcinoma
- Locally Advanced Large Cell Neuroendocrine Carcinoma of the Lung
- Locally Advanced Extrapulmonary Neuroendocrine Carcinoma
- Locally Advanced Neuroendocrine Prostate Cancer
- Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine
- Locally Advanced Merkel Cell Carcinoma
- Metastatic Large Cell Neuroendocrine Carcinoma of the Lung
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental BL-M14D1 administered Day 1 per cycle |
BL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks |
|
Recruiting Locations
Valkyrie Clinical Trials
Los Angeles, California 90067
Los Angeles, California 90067
Yale Cancer Center
New Haven, Connecticut 06520-8028
New Haven, Connecticut 06520-8028
John Theurer Cancer Center-Hackensack
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Rutgers Cancer Institute
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Ohio State University
Columbus, Ohio 43201
Columbus, Ohio 43201
Providence Cancer Institute
Portland, Oregon 97213
Portland, Oregon 97213
Prisma Health Cancer Institute
Greenville, South Carolina 29605
Greenville, South Carolina 29605
NEXT Dallas
Dallas, Texas 75039
Dallas, Texas 75039
START Dallas- Fort Worth
Dallas, Texas 76104
Dallas, Texas 76104
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
START- San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
NEXT Oncology Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington 98195
Seattle, Washington 98195
More Details
- Status
- Recruiting
- Sponsor
- SystImmune Inc.
Detailed Description
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