Melanoma study: ENV-501
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
ClinicalTrials.gov ID: NCT06956690
What this study is testing
What is ENV-501?
an investigational HER3‑targeted antibody‑drug conjugate being studied as a potential treatment for melanoma (skin) is designed to deliver a chemotherapy payload directly to HER3‑expressing cancer cells
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe HMBD-501 is, how the body handles it, and whether it shows any early signs of working against the cancer. It will also find the best dose to use in later testing.
- Who it's for
- Adults whose advanced melanoma, non‑small cell lung cancer, or breast cancer tumors show the HER3 protein and have progressed after standard treatments.
- What's involved
- Participants will receive HMBD-501, starting with low doses that increase in later groups, then the chosen dose in the expansion part. They will have regular clinic visits for drug administration, blood tests, and imaging scans to check safety and tumor response.
- Time commitment
- The trial runs for several months, with clinic visits every few weeks for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Body weight ≥ 40 kg.
- Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
- Unresectable or metastatic cutaneous melanoma (HER3+)
- Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
- Unresectable, locally advanced or metastatic breast cancer
You likely can't join if
- 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.
- CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.
See the full eligibility criteria
- Body weight ≥ 40 kg.
- Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
- Unresectable or metastatic cutaneous melanoma (HER3+)
- Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
- Unresectable, locally advanced or metastatic breast cancer
- 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...
- 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.
- 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.
- 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.
- 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Indianapolis, Indiana, United States
- Farmington Hills, Michigan, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Indianapolis, Indiana, United States; Farmington Hills, Michigan, United States; Dallas, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.