Safety and Activity of HF50 in Patients With Advanced Solid Tumors

NCT07601334 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HF50-102
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the safety, tolerability, and pharmacokinetics of HF50 in participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Dose Limiting Toxicities (DLT)

  The number of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period to determine the maximum tolerated dose (MTD).

  28 days after the first dose (C1D1) for each dose cohort.

• Incidence of Adverse Events (AEs)

  The number and percentage of participants experiencing adverse events (AEs), graded according to NCI-CTCAE v5.0

  From first dose to 28 days after the last dose.

• Recommended Phase II Dose (RP2D) of HF50

  RP2D will be determined based on safety, tolerability, and pharmacokinetics data collected during the dose escalation phase.

  At the end of dose escalation (assessed up to 1 year)

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

HF50

EXPERIMENTAL

HF50 monotherapy

Drug: HF50

Interventions

HF50 DRUG

HF50 is an innovative liposome-encapsulated bifunctional therapeutic designed to redirect T-cells to HER2-expressing tumor cells while simultaneously activating innate immunity through TLR7/8 agonism.

HF50

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HighField Biopharmaceuticals Corporation: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

Central Study Contacts

xun Wang

CONTACT

+86-571-86961869; wangxun717416@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)