New liposome drug takes aim at Hard-to-Treat cancers
NCT ID NCT07601334
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors