Recruiting

Testing a new cancer treatment targeting HER3-expressing tumors

Plain-English translation of NCT06956690 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

This is one of the first times this treatment has been tested in people.

What is this trial?

This is a first-in-human trial testing a new medication called HMBD-501 to treat advanced cancers that have stopped responding to standard therapies. The study will first figure out the safest dose by gradually increasing how much medication patients receive, then test whether that dose actually shrinks tumors. Researchers will monitor your health closely to understand how the medication works in your body and what side effects it may cause.

Many patients with advanced melanoma, lung cancer, and breast cancer run out of effective treatment options when their cancer stops responding to standard drugs. This medication targets a specific protein called HER3 that appears on certain cancer cells, offering a potential new path forward for people in this situation.

Do you qualify?

You likely qualify if…

you weigh at least 40 kilograms (about 88 pounds)
you have been diagnosed with advanced or metastatic melanoma, lung cancer, breast cancer, or certain other solid tumors whose cancer cells express HER3
your cancer is relapsed, refractory to standard treatment, or you are ineligible for or have refused standard therapies
you have a performance status of 0–2 (meaning you are well enough to tolerate treatment, though you may have some limitations in daily activities)
you are willing to use reliable contraception for at least 6 months after your last dose if you are of childbearing potential or sexually active

You likely don't qualify if…

you have received other cancer drugs, investigational treatments, major surgery, or radiation within the past 3–4 weeks
you have received a stem cell or organ transplant within the past 3 months
you are taking strong medications that interfere with how your body breaks down drugs (such as certain CYP3A4 inhibitors)
you are pregnant, breastfeeding, or planning to become pregnant or father a child during the study and for 6 months afterward

What participation looks like

You will receive the medication by intravenous infusion (through a vein) once every 3 weeks. During Phase 1, researchers will gradually increase the dose in small groups of patients to find the safest and most effective amount. In Phase 2, more patients will receive the selected dose to see how well it works against cancer. You will have regular blood tests, imaging scans, and clinic visits to monitor how you are responding and any side effects you may experience.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

Testing a new cancer treatment targeting HER3-expressing tumors

What is this trial?

Do you qualify?

What participation looks like

Trial locations(7 sites)