Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06956690
The ClinicalTrials.gov registry entry for NCT06956690 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Hummingbird Bioscience, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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
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.
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.