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

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 recommende

Trial Details

NCT ID
NCT06956690
Phase
PHASE1 / PHASE2
Sponsor
Hummingbird Bioscience
Status
RECRUITING
Cancer Type
Small Cell (SCLC) Lung Cancer
Interventions
  • ENV-501
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • Farmington Hills, Michigan, United States|42.48531,-83.37716
  • Dallas, Texas, United States|32.78306,-96.80667
  • San Antonio, Texas, United States|29.42412,-98.49363

Key Eligibility Criteria

  • Body weight ≥ 40 kg.
  • Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
  • Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractor…
  • Unresectable or metastatic cutaneous melanoma (HER3+)

For full eligibility, visit ClinicalTrials.gov.

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