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
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed the informed consent form voluntarily and agreed to follow the trial requirements 2. Age ≥18 years 3. Participant weighs more than 40 kg 4. Life expectancy of ≥3 months 5. 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 eviden…
Interventions
- DrugBL-M14D1
BL-M14D1 will be administered on D1 every 3 weeks.
Locations (20)
- 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
- Emory WinshipAtlanta, Georgia