RecruitingPhase 1Phase 2NCT06956690

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

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

Sponsor

Hummingbird Bioscience

Enrollment

180 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma (Skin)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase trial testing a new drug called HMBD-501 in people with advanced or metastatic solid tumors. The drug targets a protein called HER3, which is found on the surface of certain cancer cells. Researchers want to find the safest dose, understand how the body processes the drug, and get early signs of whether it works. **You may be eligible if...** - You are 18 or older and weigh at least 40 kg (about 88 lbs) - You have been diagnosed with an advanced or metastatic solid tumor that has the HER3 protein, such as melanoma, lung cancer (NSCLC with EGFR mutation), breast cancer, or pancreatic cancer - Your cancer has come back or stopped responding to standard treatments - You are in reasonably good overall health (able to care for yourself) **You may NOT be eligible if...** - Your cancer does not have the HER3 protein - You have untreated or active cancer in the brain or spinal cord - Your heart, liver, or kidneys are not functioning well - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALENV-501

ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.