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.
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+)
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.
Single group
ENV-501
Biological/VaccineENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.
Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events
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).
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.
Phase 1 (Dose Escalation): Objective Response Rate (ORR)
Phase 1 (Dose Escalation): maximum blood concentration (Cmax) after a single dose
Phase 1 (Dose Escalation): time of maximum blood concentration (Tmax) after a single dose
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