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Smart chemo: new drug aims to hit HER-2 cancers harder

NCT ID NCT05861895

Disease control Sponsor: HighField Biopharmaceuticals Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing a new drug called HF158K1 in 84 adults with advanced solid tumors that have HER-2 protein. The drug is a form of chemotherapy wrapped in a fat bubble that carries a targeting molecule to seek out HER-2 cancer cells. The main goals are to check safety, find the right dose, and see early signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HF158K1 (a liposome form of doxorubicin with a HER2-targeting antibody fragment)
What this could lead to
If it works, this could point toward a more targeted chemotherapy for HER-2 positive cancers, potentially reducing side effects.
What could go wrong
This is a very early Phase 1 trial with only 84 people, focused on safety and dosing. It may not show strong anti-tumor effects, and side effects could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary to participate and sign ICF. 2. Age ≥ 18 and ≤ 75 years. 3. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+). 4. ECOG score 0-1. 5. Expected survival ≥ 6 months. 6. At least one measurable lesion per RECIST v1.1. 7. Adequate organ function: ANC ≥ 1.5×10⁹/L, LYM ≥ 1.0×10⁹/L, PLT ≥ 90×10⁹/L, HGB ≥ 8.0 g/dL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL/min; LVEF ≥ 50%. 8. Agreement to use effective contraception. Exclusion Criteria: 1. Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity. 2. Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone). 3. Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C). 4. Symptomatic CNS metastases. 5. Unresolved AEs from prior therapy \> Grade 1. 6. Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension). 7. Active infection or unexplained fever \> 38.5°C. 8. HIV, active HBV or HCV. 9. Pregnant or breastfeeding.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75241, United States

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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