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.