Melanoma (Skin)Phase 1/2NCT06956690
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 1/2 study testing ENV-501 in people with Melanoma (Skin) and Non Small Cell Lung Cancer, run by Hummingbird Bioscience at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Non Small Cell Lung Cancer, Breast Cancer
- What is being tested?
- ENV-501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Dec 2025to Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Unresectable or metastatic cutaneous melanoma (HER3+)
- Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
- Unresectable, locally advanced or metastatic breast cancer
Show all 19Show fewer
- Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinoma (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.
- 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:
- Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.
- Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.
- Females must:
- Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.
- Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.
- Males must:
- Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.
- Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:
- Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).
- Treatment with investigational drugs within 21 days.
- Major surgery within 21 days.
- Radiation therapy ≤4 weeks or radiotherapy that included >30% of the bone marrow.
- Autologous or allogeneic stem cell transplantation or allogeneic tissue/organ transplant within 3 months.
Show all 20Show fewer
- CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.
- CYP3A4 strong inducer ≤4 half-lives.
- OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Hummingbird Bioscience Team contact
7 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Research Site
Dallas, Texas, 75230
HMBD Patients <patients@hummingbirdbio.com>
- Recruiting
Research Site
Farmington Hills, Michigan, 48334
HMBD Patients <patients@hummingbirdbio.com>
- Recruiting
Research Site
Indianapolis, Indiana, 46250
HMBD Patients <patients@hummingbirdbio.com>
- Recruiting
Research Site
La Jolla, California, 92093
HMBD Patients <patients@hummingbirdbio.com>
- Recruiting
Research Site
San Antonio, Texas, 78229
HMBD Patients <patients@hummingbirdbio.com>
Australia2 sites
- Withdrawn
Research Site
Campbelltown, New South Wales, 2560
- Withdrawn
Research Site
Miranda, New South Wales, 2228
About this study
Official title: A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory 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 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
- Melanoma (Skin), Non Small Cell Lung Cancer, Breast Cancer
- Being tested
- ENV-501
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENV-501Biological
ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.
| Study group | Role | What they receive |
|---|---|---|
| HMBD-501 | Experimental | HMBD-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of HMBD-501 until the RP2D is reached Receives: Biological: ENV-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Objective Response Rate (ORR)
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).
Measured: through study completion, an average of 6 months
Secondary outcomes (24)
Phase 1 (Dose Escalation): Disease Control Rate (DCR)
DCR is defined as CR, PR, or Stable Disease (SD) by investigator assessment, measured by revised RECIST 1.1.
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Objective Response Rate (ORR)
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): maximum blood concentration (Cmax) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): time of maximum blood concentration (Tmax) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): absorption to time t (AUC0-t) after a single dose
AUC represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time 't'
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): absorption to end of the dosing period (AUC0-tau) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): total absorption (AUC0-infinity) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): drug half-life (t1/2) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): minimum blood concentration (Cmin) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): rate of clearance (CL) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): steady-state volume of distribution (Vss) after a single dose
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): Cmax at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Tmax at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): AUC0-t at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation):AUC0-tau at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): t1/2 at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Cmin at steady state
Measured: through study completion, an average of 6 months
Phase 1 (Dose Escalation): accumulation ratio at steady state
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Disease Control Rate (DCR)
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Duration of Response (DoR)
A DoR event is defined as disease progression or death due to any cause in the subset of patients who achieved CR or PR on the study. DoR will be calculated from the date of first radiographic evidence of objective response by RECIST v1.1 to the date of progression, date of death, or date of last follow-up, whichever is the earliest.
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Progression-free Survival (PFS)
A PFS event is defined as disease progression or death due to any cause. PFS will be calculated from the date of treatment start to the date of progression, date of death, or date of last follow-up, whichever is the earliest.
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Frequency of treatment-emergent adverse events
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Cmax at steady state
Measured: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Cmin at steady state
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start17 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hummingbird Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Heller, Study director, Hummingbird Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956690
- Sponsor's protocol ID
- HMBD-501-101
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors
- ClinicalTrials.gov ID
- NCT06956690
- Acronym / sponsor ID
- HMBD-501-101
- Conditions
- Melanoma (Skin), Non Small Cell Lung Cancer, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hummingbird BioscienceIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMBD-501 | Experimental | Biological: ENV-501HMBD-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of HMBD-501 until the RP2D is reached |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENV-501ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker. | Biological | HMBD-501 |
Primary outcome
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Objective Response Rate (ORR)
Time frame: 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).
24 secondary outcomes
Phase 1 (Dose Escalation): Disease Control Rate (DCR)
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Objective Response Rate (ORR)
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): maximum blood concentration (Cmax) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): time of maximum blood concentration (Tmax) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): absorption to time t (AUC0-t) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): absorption to end of the dosing period (AUC0-tau) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): total absorption (AUC0-infinity) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): drug half-life (t1/2) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): minimum blood concentration (Cmin) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): rate of clearance (CL) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): steady-state volume of distribution (Vss) after a single dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (Dose Escalation): Cmax at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Tmax at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): AUC0-t at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation):AUC0-tau at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): t1/2 at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): Cmin at steady state
Time frame: through study completion, an average of 6 months
Phase 1 (Dose Escalation): accumulation ratio at steady state
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Disease Control Rate (DCR)
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Duration of Response (DoR)
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Progression-free Survival (PFS)
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Frequency of treatment-emergent adverse events
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Cmax at steady state
Time frame: through study completion, an average of 6 months
Phase 2 (Dose Expansion): Cmin at steady state
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hummingbird Bioscience Team contact
Kevin Heller study director
Hummingbird Bioscience
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ENV-501 in people with Melanoma (Skin) and Non Small Cell Lung Cancer, run by Hummingbird Bioscience at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Heller, Dr (+65 6978 9377, HMBD Patients <patients@hummingbirdbio.com>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.