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 (May 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
Cancer type
Melanoma
Small Cell Lung Cancer
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 →
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