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NCT06714617 · ClinicalTrials.gov registry record · Phase 1
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Fallopian Tube Cancer, sponsored by SystImmune.
- Active
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 9
- Study locations
NCT06714617: Active Phase 1 study of Non-Small Cell Lung Cancer and Fallopian Tube Cancer, sponsored by SystImmune.
NCT06714617 is a Phase 1 study of Non-Small Cell Lung Cancer and Fallopian Tube Cancer that is active but no longer recruiting, run by SystImmune. The registered enrollment target is 120 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (82% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06714617, a Phase 1 study of Non-Small Cell Lung Cancer and Fallopian Tube Cancer, is active but no longer recruiting, sponsored by SystImmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 9
- Study locations
Study Summary
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
Primary Outcome
Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: 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 \>7 days Nonhematologic toxicities * Death not clearly related to disease pro
Conditions Studied
Interventions
- DRUG BL-M17D1
Study Locations (9)
Florida
- SCRI-Florida Cancer Center Specialists Lake Mary - Lake Mary
- Hematology Oncology Associates of the Treasure Cost - Port Saint Lucie
- SCRI-Florida Cancer Center Specialists Sarasota - Sarasota
Colorado
- SCRI-Denver HealthOne - Denver
Connecticut
- Yale Cancer Center - New Haven
Massachusetts
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- SCRI-Sidney Kimmel Cancer Center - Philadelphia
Tennessee
- SCRI-Oncology Partners - Nashville
Virginia
- NEXT Oncology - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-04-10 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What the registry record for NCT06714617 still lists
NCT06714617 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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (82% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which BL-M17D1 is the first listed.
NCT06714617 lists 9 locations in 7 states (Florida, Colorado, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06714617 about?
NCT06714617 is a clinical study titled "Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors". The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
What is the current status of trial NCT06714617?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2025-04-10. Estimated completion is 2027-12-01.
What conditions does trial NCT06714617 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Gastroesophageal-junction Cancer, Breast Cancer Stage III.
What interventions are being tested in trial NCT06714617?
The interventions under investigation include: BL-M17D1 (DRUG).
Who is sponsoring clinical trial NCT06714617?
This trial is sponsored by SystImmune, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06714617 being conducted?
This trial has 9 study locations across Colorado, Connecticut, Florida, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06714617's enrollment target sits among peer trials
120 219th of 454 higher than 234 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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