Phase 12 Study of HMBD-501 to Evaluate Safety and Early Effectiveness in Adults With Advanced HER3-Positive Solid Tumors

What this Trial Is About

Researchers are evaluating HMBD-501, a HER3-targeted antibody-drug conjugate, in patients with advanced, relapsed, or refractory HER3-expressing solid tumors including melanoma, non-small cell lung cancer, and breast cancer. This Phase 12 trial aims to assess the safety, tolerability, how the drug moves in the body, and early signs of effectiveness. The study is sponsored by Hummingbird Bioscience and includes two parts a dose escalation phase followed by a dose expansion phase. During Phase 1, patients receive increasing doses of HMBD-501 by intravenous injection every three weeks to find the recommended dose for Phase 2. In Phase 2, patients receive this recommended dose to further evaluate the drugs preliminary clinical effects. The dose escalation helps identify the safest and most effective dose schedule for treating these advanced tumors. Participants will have regular visits for treatment, monitoring, and assessments including safety checks and blood tests to measure drug levels. The main outcomes include tracking any side effects during Phase 1 and measuring tumor responses in Phase 2 over about six months. Researchers will also study how the drug behaves in the body and monitor disease control and progression. Participants must follow the visit schedule and study procedures throughout the trial.

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