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
SystImmune Inc.
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 Neoplasms
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 p…
Interventions
- DrugBL-M14D1
BL-M14D1 will be administered on D1 every 3 weeks.
Locations (20)
- Clearview Cancer InstituteHuntsville, Alabama
- Valkyrie Clinical TrialsLos Angeles, California
- UCLALos Angeles, California
- UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)San Francisco, California
- University of Colorado - Anschutz Cancer PavilionAurora, Colorado
- Yale Cancer CenterNew Haven, Connecticut