Actively Recruiting
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
Led by Hummingbird Bioscience · Updated on 2026-03-02
180
Participants Needed
7
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight 2 40 kg
- Willing and able to provide signed written informed consent before any study-related screening procedures
- Histologically or cytologically confirmed advanced-stage or metastatic HER3+ solid tumors relapsed, refractory, or ineligible for standard therapy
- Includes unresectable or metastatic cutaneous melanoma (HER3+), locally advanced or metastatic mutated EGFR NSCLC (HER3+), unresectable, locally advanced or metastatic breast cancer
- Relapsed or refractory HER3+ solid tumors such as pancreatic ductal adenocarcinoma and gastric cancers may be allowed with sponsor approval
- Willingness to undergo fresh tumor biopsy if HER3+ status report unavailable
- Eastern Cooperative Oncology Group performance status 0-2
- Women of childbearing potential must use contraception from 28 days before study through 6 months after last dose
- Sexually active males with female partners of childbearing potential must use condoms with spermicide from study start through 6 months after last dose
- Females agree not to donate eggs or breastfeed and not plan pregnancy during study and 6 months after last dose
- Males agree not to donate sperm or father a child during study and for 6 months after last dose
- Willing and able to comply with scheduled visits, treatment plan, lab tests, and study procedures
You will not qualify if you...
- Anti-tumor drug therapy within 21 days or 5 times elimination half-life before study drug administration
- Treatment with investigational drugs within 21 days
- Major surgery within 21 days
- Radiation therapy within 4 weeks or radiation including >30% bone marrow
- Stem cell or tissue/organ transplant within 3 months
- Use of CYP3A4 strong inhibitor, inducer, or OATP1B inhibitor within 4 half-lives
- Prior treatment with HER3-targeted ADC or exatecan-derivative ADC as last therapy
- Prior treatment with topoisomerase I inhibitor as last therapy
- Primary immune deficiency
- Active uncontrolled infection requiring intravenous antibiotics or antivirals within 2 weeks
- Known or suspected hypersensitivity to ENV-501 or related antibodies
- History of pneumonitis or interstitial lung disease
- Known positive HIV, hepatitis B or C (except after vaccination or confirmed cure)
- Leptomeningeal disease or symptomatic, uncontrolled brain metastasis
- Pregnant or women of childbearing potential with positive pregnancy test
- Active second malignancies requiring therapy
- Immediate family member of study site personnel or sponsor personnel
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Research Site
La Jolla, California, United States, 92093
Actively Recruiting
2
Research Site
Indianapolis, Indiana, United States, 46250
Actively Recruiting
3
Research Site
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
4
Research Site
Dallas, Texas, United States, 75230
Actively Recruiting
5
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Research Site
Campbelltown, New South Wales, Australia, 2560
Withdrawn
7
Research Site
Miranda, New South Wales, Australia, 2228
Withdrawn
Research Team
K
Kevin Heller, Dr
CONTACT
H
Hummingbird Bioscience Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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