Back to search results

Phase 1/2 Study of HMBD-501 for HER3-Expressing Solid Tumors

This Phase 1/2 clinical trial is testing a new treatment called HMBD-501 for people with advanced solid tumors that have a specific marker called HER3. HMBD-501 is an antibody-drug conjugate (ADC), which means it's designed to deliver chemotherapy directly to cancer cells. The study aims to find out if HMBD-501 is safe, how well your body handles it, and if it can shrink tumors. You might be able to join if you have advanced melanoma, non-small cell lung cancer, or breast cancer that has HER3 and has not responded to standard treatments, or if standard treatments are not an option. The study will first look at safety and then at how many patients respond to the treatment. The current status of this study is unclear.

Study design
This is a Phase 1/2, first-in-human, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 180 participants.
What's involved
The study will assess side effects through study completion, which is an average of 6 months. Objective Response Rate will also be measured through study completion, an average of 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06956690

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hummingbird Bioscience
~180 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:ENV-501

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
Measured over through study completion, an average of 6 months
+1 more outcome measured

Conditions

Melanoma (Skin)
Non Small Cell Lung Cancer
Breast Cancer

Explore related trials

Breast CarcinomaGastric CarcinomaLung Non-Small Cell CarcinomaMelanomaPancreatic Ductal AdenocarcinomaSolid Neoplasm

Where it's being run

7 sites across 5 states
Texas2
New South Wales2
California1
Indiana1
Michigan1

Study leadership

  • Kevin Heller · STUDY_DIRECTOR · Hummingbird Bioscience

Who to contact

Kevin Heller, Dr
HMBD Patients <[email protected]>
+65 6978 9377
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Body weight ≥ 40 kg.
Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:
If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status following enrollment..
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Contraceptive requirements:
Females must:
Males must:
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion

Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:
Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.
Prior treatment with a topoisomerase I inhibitor as last line of therapy.
Primary immune deficiency (e.g. congenital syndromes).
Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.
Known/suspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.
History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).
Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for ≥4 weeks prior to study start and patient is neurologically stable).
Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.
Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.
Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.

What this trial measures

  • Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse eventsthrough study completion, an average of 6 months
  • Phase 2 (Dose Expansion): Objective Response Rate (ORR)through study completion, an average of 6 months

    Objective Response is defined as Complete Response (CR) or Partial Response (PR) by investigator assessment, measured by revised Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).