Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

HF50 safety and activity in advanced solid tumors

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of HF50 in Patients With Advanced Solid Tumors

Run by HighField Biopharmaceuticals Corporation · NCT07601334 · Data updated 2026-11-12

This study tests HF50, a targeted therapy, to see if it is safe and can help people with advanced solid tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment45 (estimated)
SponsorHighField Biopharmaceuticals Corporation
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations2 sites (Beijing, Beijing Municipality and 1 other locations)
StatusRecruiting
StartedSeptember 8, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2029
Registry record updatedSeptember 28, 2026
Trial IDNCT07601334 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older with unresectable or metastatic advanced solid tumors, who have failed or are intolerant to standard therapies and have measurable disease with good performance status.

Probably not a fit

Patients with certain contraindications or lacking measurable disease, or those unable to tolerate IV therapy, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label trial using dose-escalation and dose-expansion to evaluate HF50 as a monotherapy in adults with advanced solid tumors. HF50 is a liposome-encapsulated T-cell engager that redirects T-cells to tumor cells and releases a TLR7/8 agonist to stimulate the immune response. The study aims to determine safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity, along with effects on the immune microenvironment. Participants will receive intravenous HF50 infusions with ongoing safety monitoring to establish a recommended Phase 2 dose. Exploratory analyses include immune cell and cytokine changes in blood and potential biomarkers of response.

Why it matters

Potential benefit: If successful, HF50 could provide a new approach that activates the immune system to fight tumors and offer potential anti-tumor activity for patients with limited options.

How similar studies have gone: Previous similar immunotherapy approaches have shown activity in select solid tumors, but this exact HF50 construct represents a novel combination and requires confirmation in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.