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 (NCT06956690)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research Site — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Research Site — La Jolla, California
- Research Site — Indianapolis, Indiana
- Research Site — Farmington Hills, Michigan
- Research Site — Dallas, Texas
- Research Site — San Antonio, Texas
- Research Site — Campbelltown, New South Wales
- Research Site — Miranda, New South Wales
📞 Contact the Study Coordinator
Phone: (656) 978-9377
Email: HMBD Patients <patients@hummingbirdbio.com>
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma (Skin)
- High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma — Birmingham, Alabama
- Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma — Tampa, Florida
- A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma — Toronto, Ontario
- Zr89 + PET Companion Trial — Philadelphia, Pennsylvania
- Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma — Orange, California
Explore by condition: All Melanoma (Skin) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.