OncoMatch/Clinical Trials/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
Is NCT06956690 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies ENV-501 for melanoma (skin).
Treatment: ENV-501 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Melanoma
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Biomarker criteria
Required: ERBB3 overexpression (HER3+)
HER3+ solid tumors; molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status
Allowed: EGFR mutation
Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
Disease stage
Required: Stage ADVANCED-STAGE, III, IV
advanced-stage or metastatic HER3+ solid tumors; unresectable or metastatic cutaneous melanoma; locally advanced or metastatic mutated EGFR (mEGFR) NSCLC; unresectable, locally advanced or metastatic breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
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
Cannot have received: HER3-targeted antibody-drug conjugate
Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy
Cannot have received: topoisomerase I inhibitor
Prior treatment with a topoisomerase I inhibitor as last line of therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Dallas, Texas
- Research Site · San Antonio, Texas
- Research Site · La Jolla, California
- Research Site · Indianapolis, Indiana
- Research Site · Farmington Hills, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06956690 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER3-targeted antibody-drug conjugate, topoisomerase I inhibitor disqualifies patients from enrollment.
Does this trial require ERBB3?
Yes, ERBB3 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage ADVANCED-STAGE or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages