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NCT06956690 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Hummingbird Bioscience.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 7
- Study locations
NCT06956690: Recruiting Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Hummingbird Bioscience.
NCT06956690 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that is actively recruiting participants, run by Hummingbird Bioscience. The registered enrollment target is 180 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06956690, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Hummingbird Bioscience.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of HMBD-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of HMBD-501. The results of the dose escalation will determine the RP2D and dosing schedule of HMBD-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of HMBD-501 in dose expansion cohorts.
Conditions Studied
Interventions
- BIOLOGICAL ENV-501
Study Locations (7)
Texas
- Research Site - Dallas
- Research Site - San Antonio
New South Wales
- Research Site - Campbelltown
- Research Site - Miranda
California
- Research Site - La Jolla
Indiana
- Research Site - Indianapolis
Michigan
- Research Site - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06956690 shows while recruiting
NCT06956690 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (94% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which ENV-501 is the first listed.
NCT06956690 lists 7 locations in 5 states (Texas, New South Wales, California).
Frequently Asked Questions
What is clinical trial NCT06956690 about?
NCT06956690 is a clinical study titled "A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors". This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The stu...
What is the current status of trial NCT06956690?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2025-12-17. Estimated completion is 2027-07.
What conditions does trial NCT06956690 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Melanoma (Skin).
What interventions are being tested in trial NCT06956690?
The interventions under investigation include: ENV-501 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06956690?
This trial is sponsored by Hummingbird Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06956690 being conducted?
This trial has 7 study locations across California, Indiana, Michigan, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06956690's enrollment target sits among peer trials
180 406th of 1224 higher than 817 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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