A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

NCT06956690 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Hummingbird Bioscience
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	180
Start date	2025-12-17
Completion	2027-07

Conditions

• Melanoma (Skin)
• Non Small Cell Lung Cancer
• Breast Cancer

Interventions

• ENV-501

Primary outcomes

• Phase 1 (Dose Escalation): Frequency of treatment-emergent adverse events — through study completion, an average of 6 months
• Phase 2 (Dose Expansion): Objective Response Rate (ORR) — 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).

Countries

United States, Australia