NCT06956690 · Endeavor Biomedicines, Inc.
A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With HER3-Expressing Solid Tumors
What this study is about
This study is a Phase 1/2, first-in-human, where both patients and doctors know the treatment given, clinical trial to assess the safety, tolerability, how the drug moves through the body and preliminary effectiveness of ENV-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors.
View original scientific description
This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of ENV-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).
Interventions
BIOLOGICAL
ENV-501
ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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: 1. Unresectable or metastatic cutaneous melanoma (HER3+) 2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+) 3. Unresectable, locally advanced or metastatic hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)- breast cancer (HER3+)
- If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for assessment of HER3+ status.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-
Where
- La Jolla, California
- Indianapolis, Indiana
- Farmington Hills, Michigan
- Dallas, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations