A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors
SystImmune Inc.
Summary
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
Description
This is a multicenter Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M05D1 in subjects with unresectable locally advanced or metastatic solid tumors that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant/neoadjuvant), have no other standard of care options, and have no available curative options. This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Subjects will be dosed on Day…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed the informed consent form voluntarily and agreed to follow the program requirements 2. Age: ≥18 years 3. Has a life expectancy of ≥3 months 4. Has documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant/neoadjuvant), have no other standard of care options, and have no available curative options, including: 1. Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Subjects with CLDN18.2, h…
Interventions
- DrugBL-M05D1
BL-M05D1 will be administered on D1 every 3 weeks.
Locations (17)
- Mayo Clinic Cancer Center- PhoenixPhoenix, Arizona
- HonorHealthScottsdale, Arizona
- University of Colorado HealthAurora, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Ochsner Medical CenterNew Orleans, Louisiana
- University of MichiganAnn Arbor, Michigan