Safety and Activity of HF50 in Patients With Advanced Solid Tumors

May 15, 2026 updated by: HighField Biopharmaceuticals Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, dose-escalation and dose-expansion, multiple-dose, phase 1 study evaluating HF50 monotherapy in participants with advanced solid tumors. HF50 is an innovative liposome-encapsulated T-cell engager designed to redirect T-cells to tumor cells by presenting both tumor-associated antigen (e.g., HER2) and CD3 targeting moieties on the liposome surface. Simultaneously, HF50 delivers an encapsulated TLR7/8 agonist to activate innate immunity and remodel the tumor immune microenvironment, creating a synergistic anti-tumor immune response.The primary objective is to evaluate the safety and tolerability of HF50 and to determine the recommended Phase 2 dose (RP2D). HF50 will be administered as an intravenous (IV) infusion. The study will also assess the pharmacokinetic (PK) profile, immunogenicity, and preliminary anti-tumor activity of HF50. Additionally, the study will explore the impact of HF50 on the immune microenvironment and changes in peripheral blood cytokines and immune cells to better understand its biological effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jing Li, MD, PhD
        • Principal Investigator:
          • Qiong Yang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HF50
HF50 monotherapy
Drug: HF50
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicities (DLT)
Time Frame: 28 days after the first dose (C1D1) for each dose cohort.
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)
Time Frame: From first dose to 28 days after the last dose.
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
Time Frame: At the end of dose escalation (assessed up to 1 year)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 2 years
Proportion of participants achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria.
Up to 2 years
Duration of Response (DOR)
Time Frame: Up to 2 years
Time from the first documented response (CR or PR) to disease progression or death.
Up to 2 years
Disease Control Rate (DCR)
Time Frame: Up to 2 years
Proportion of participants achieving CR, PR, or stable disease (SD) based on RECIST v1.1.
Up to 2 years
Progression-Free Survival (PFS)
Time Frame: Up to 2 years
Time from the first dose to disease progression or death.
Up to 2 years
Overall Survival (OS)
Time Frame: Up to 2 years
Time from the first dose to death from any cause.
Up to 2 years
Pharmacokinetic Parameter - Cmax
Time Frame: Up to 2 years
Maximum plasma concentration (Cmax) of HF50 will be assessed following single and multiple dosing.
Up to 2 years
Pharmacokinetic Parameter - Tmax
Time Frame: Up to 2 years
Time to maximum plasma concentration (Tmax) of HF50 will be assessed following single and multiple dosing.
Up to 2 years
Pharmacokinetic Parameter - AUC (Area Under the Curve)
Time Frame: Up to 2 years
AUC0-t and AUC0-inf will be evaluated to determine systemic exposure to HF50.
Up to 2 years
Pharmacokinetic Parameter - Half-life (t1/2)
Time Frame: Up to 2 years
The terminal elimination half-life (t1/2) of HF50 will be calculated.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HighField Biopharmaceuticals Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HF50-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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