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NCT07021066 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
A Phase 1 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by SystImmune.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 17
- Study locations
NCT07021066: Recruiting Phase 1 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by SystImmune.
NCT07021066 is a Phase 1 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma that is actively recruiting participants, run by SystImmune. The registered enrollment target is 120 participants, below the 243-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (51% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07021066, a Phase 1 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, is actively recruiting participants, sponsored by SystImmune.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
A DLT is defined as the following: Toxicity that results in a \>14-day delay in treatment \- Hematologic toxicities Grade 4 neutrophil count decreased lasting \>7 days Grade ≥3 febrile neutropenia of any duration Grade ≥3 platelet count decreased with clinically significant hemorrhage Grade 4 thrombocytopenia lasting \>72 hours \- Nonhematologic toxicities Death not clearly related to disease progression or extraneous cause Hy's law cases Grade ≥3 nonhematologic toxicities, except for:
Conditions Studied
Interventions
- DRUG BL-M05D1
Study Locations (17)
Texas
- NEXT Oncology- Austin - Austin
- NEXT Oncology- Dallas - Dallas
- MD Anderson - Houston
- NEXT Oncology San Antonio - San Antonio
- START Center for Care Center- San Antonio - San Antonio
- Baylor Scott and White Medical Center- Temple Clinic - Temple
Arizona
- Mayo Clinic Cancer Center- Phoenix - Phoenix
- HonorHealth - Scottsdale
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
Tennessee
- Sarah Cannon Research Institute - Oncology Partners - Nashville
- Vanderbilt-Ingram Cancer Center - Nashville
Colorado
- University of Colorado Health - Aurora
Connecticut
- Yale Cancer Center - New Haven
Louisiana
- Ochsner Medical Center - New Orleans
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-07-30 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
What NCT07021066 shows while recruiting
NCT07021066 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 243-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (51% lower).
The record links to 5 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which BL-M05D1 is the first listed.
NCT07021066 lists 17 locations in 9 states (Texas, Arizona, Michigan).
Frequently Asked Questions
What is clinical trial NCT07021066 about?
NCT07021066 is a clinical study titled "Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors". 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.
What is the current status of trial NCT07021066?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2025-07-30. Estimated completion is 2027-05-31.
What conditions does trial NCT07021066 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Biliary Tract Cancer, Advanced Pancreatic Ductal Adenocarcinoma, Other Solid Tumors.
What interventions are being tested in trial NCT07021066?
The interventions under investigation include: BL-M05D1 (DRUG).
Who is sponsoring clinical trial NCT07021066?
This trial is sponsored by SystImmune, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07021066 being conducted?
This trial has 17 study locations across Arizona, Colorado, Connecticut, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07021066's enrollment target sits among peer trials
120 18th of 47 higher than 30 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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