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NCT05983432 · ClinicalTrials.gov registry record · Phase 1
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by SystImmune.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 470
- Enrollment target
- 20
- Study locations
NCT05983432: Recruiting Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by SystImmune.
NCT05983432 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that is actively recruiting participants, run by SystImmune. The registered enrollment target is 470 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05983432, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by SystImmune.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 470 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other 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: Hematological toxicities: * Grade 4 neutrophil count decreased lasting \>7 days * Grade ≥3 febrile neutropenia * Grade ≥3 platelet count decreased with clinically significant hemorrhage. Non-Hematological toxicities: * Death * Hy's law cases * Grade ≥3 non-hematological toxicities,
Conditions Studied
Interventions
- DRUG BL-B01D1
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- City of Hope Cancer Center - Duarte
- Chao Family Comprehensive Cancer Care and Ambulatory Care - Irvine
- Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- University of California Irvine Medical Center - Orange
- UCLA Santa Monica - Santa Monica
Florida
- Sylvester Comprehensive Cancer Center - Miami
- Sara Cannon Research Institute Lake Nona - Orlando
- Hematology - Oncology Associates of the Treasure Coast - Port Saint Lucie
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- University of Colorado Cancer Center - Aurora
Connecticut
- Yale University, Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Iowa
- University of Iowa Hospital and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2028-03-21 |
| Phase | Phase 1 |
What NCT05983432 shows while recruiting
NCT05983432 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which BL-B01D1 is the first listed.
NCT05983432 names 20 study sites across 12 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05983432 about?
NCT05983432 is a clinical study titled "Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors". The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
What is the current status of trial NCT05983432?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 470 participants. The study started on 2023-08-08. Estimated completion is 2028-03-21.
What conditions does trial NCT05983432 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Lung Cancer, Ovarian Cancer, Endometrial Cancer.
What interventions are being tested in trial NCT05983432?
The interventions under investigation include: BL-B01D1 (DRUG).
Who is sponsoring clinical trial NCT05983432?
This trial is sponsored by SystImmune, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05983432 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05983432's enrollment target sits among peer trials
470 209th of 1224 higher than 1,015 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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