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New liposome drug takes aim at Hard-to-Treat cancers

NCT ID NCT07601334

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial tests a new drug called HF50 in 45 adults with advanced solid tumors that have not responded to standard treatments. HF50 is designed to target HER2 on cancer cells and boost the immune system. 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
HF50 (a liposome-encapsulated drug that targets HER2 on cancer cells and boosts immune response)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 45 participants, focused on safety and dosing. It may not show significant anti-tumor effects, and side effects are unknown.

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 45 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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 years and older

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: * Voluntary participation: Capable of giving signed informed consent and able to comply with all study-related procedures. * Age: Adults \>= 18 years of age at the time of signing informed consent; male or female. * Disease Status: Participants with histologically or cytologically confirmed advanced solid tumors that are unresectable or metastatic, who have failed or are intolerant to standard therapies, or for whom no effective therapy currently exists. Examples include HER2-expressing gynecological tumors and recurrent ovarian clear cell carcinoma after failure of platinum-based chemotherapy. * Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. * Life Expectancy: Anticipated survival of no less than 6 months. * Measurable Disease: At least one measurable lesion according to RECIST v1.1 definitions. * Organ and Bone Marrow Function: Bone Marrow Reserve: Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L, lymphocyte count \>= 1.0 x 10\^9/L, platelet count \>= 90 x 10\^9/L, and hemoglobin \>= 9.0 g/dL (no blood transfusion or hematopoietic stimulators within 14 days). Coagulation Function: Activated partial thromboplastin time (APTT) \<= 1.5 x ULN, and International Normalized Ratio (INR) \<= 1.5. Liver Function: Total bilirubin (TBIL) \<= 1.5 x ULN, and ALT and AST \<= 2.5 x ULN. For participants with liver metastases: ALT and AST \<= 5 x ULN, and TBIL \<= 3 x ULN. Renal Function: Creatinine clearance \>= 50 mL/min (calculated using the Cockcroft-Gault formula). * Contraception: Participants of reproductive potential (including males) must agree to use effective contraception from study entry through 6 months after the last dose. Female participants of childbearing potential must have a negative serum pregnancy test during screening and prior to the first dose. Exclusion Criteria: * Autoimmune Disease: Any active autoimmune disease or history of autoimmune disease deemed unsuitable by the investigator. Exceptions include skin conditions not requiring systemic treatment (e.g., eczema \< 10% of body surface area, vitiligo, psoriasis, alopecia) and resolved childhood asthma. * Corticosteroids/Immunosuppressants: Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose. Topical steroid use is permitted. * Prior Anti-tumor Therapy: Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 2 weeks prior to dosing (4 weeks for nitrosoureas or mitomycin C); or other therapies (endocrine therapy, TCM, localized palliative radiotherapy) within 2 weeks. * CNS Metastasis: Clinically symptomatic brain or meningeal metastases. Participants with treated brain metastases are eligible if radiographic stability is maintained for \>= 28 days, systemic steroids have been discontinued for \> 14 days, and the participant is asymptomatic. * Toxicity Recovery: Failure to recover from all adverse events of prior therapies to \<= Grade 1 (NCI CTCAE v5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement. * Cardiovascular History: Including thromboembolic events within 3 months; NYHA Class III to IV congestive heart failure; acute coronary syndrome, aortic dissection, stroke, or other Grade \>= 3 cardiovascular events within 6 months; or uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg). * Infection: Active infection or unexplained fever \> 38.5 degrees C within 1 week prior to the first dose (tumor-related fever is permitted per investigator judgment). * Viral Infection: HIV infection, active HBV (HBV DNA \> ULN), or active HCV (HCV RNA \> ULN). * Gastrointestinal Symptoms: Significant digestive system symptoms or other factors requiring intervention within 4 weeks prior to the first dose. * Pregnancy/Lactation: Female participants who are pregnant or breastfeeding. * Other: Any other serious systemic disease or reason that, in the investigator's opinion, makes the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

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