Trials / Recruiting
RecruitingNCT07021066
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- SystImmune Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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 1 on a continuous 21-day treatment cycle.
Conditions
- Gastric Adenocarcinoma
- Advanced Pancreatic Ductal Adenocarcinoma
- Esophageal Adenocarcinoma
- Biliary Tract Cancer
- Other Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-M05D1 | BL-M05D1 will be administered on D1 every 3 weeks. |
Timeline
- Start date
- 2025-07-30
- Primary completion
- 2027-02-28
- Completion
- 2027-05-31
- First posted
- 2025-06-13
- Last updated
- 2026-04-15
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07021066. Inclusion in this directory is not an endorsement.