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Advanced Solid TumorsPhase 1NCT07601334

Safety and Activity of HF50 in Patients With Advanced Solid Tumors

A Phase 1 study testing HF50 in people with Advanced Solid Tumors, run by HighField Biopharmaceuticals Corporation at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HF50
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesChina
Study dates
8 Sep 2026to 30 Jun 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

xun Wang contact

+86-571-86961869

wangxun717416@gmail.com

China2 sites, 2 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    FEI MA, MD,PhD

    FEI MA, MD,PhD

    Not yet recruiting

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

    Guangzhou, Guangdong, 510120

    HERUI YAO, MD,PhD, +8613500018020, yaohrsysu@163.com

    Jing Li, MD, PhD

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
HF50

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HF50Drug

    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.

Study groups in NCT07601334
Study groupRoleWhat they receive
HF50ExperimentalHF50 monotherapy
Receives: Drug: HF50

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. Incidence of Adverse Events (AEs)

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

    Measured: From first dose to 28 days after the last dose.

  3. Recommended Phase II Dose (RP2D) of HF50

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

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

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Proportion of participants achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria.

    Measured: Up to 2 years

  2. Duration of Response (DOR)

    Time from the first documented response (CR or PR) to disease progression or death.

    Measured: Up to 2 years

  3. Disease Control Rate (DCR)

    Proportion of participants achieving CR, PR, or stable disease (SD) based on RECIST v1.1.

    Measured: Up to 2 years

  4. Progression-Free Survival (PFS)

    Time from the first dose to disease progression or death.

    Measured: Up to 2 years

  5. Overall Survival (OS)

    Time from the first dose to death from any cause.

    Measured: Up to 2 years

  6. Pharmacokinetic Parameter - Cmax

    Maximum plasma concentration (Cmax) of HF50 will be assessed following single and multiple dosing.

    Measured: Up to 2 years

  7. Pharmacokinetic Parameter - Tmax

    Time to maximum plasma concentration (Tmax) of HF50 will be assessed following single and multiple dosing.

    Measured: Up to 2 years

  8. Pharmacokinetic Parameter - AUC (Area Under the Curve)

    AUC0-t and AUC0-inf will be evaluated to determine systemic exposure to HF50.

    Measured: Up to 2 years

  9. Pharmacokinetic Parameter - Half-life (t1/2)

    The terminal elimination half-life (t1/2) of HF50 will be calculated.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start8 Sep 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601334
Sponsor's protocol ID
HF50-102
Status last verified
May 2026
First submitted
15 May 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HF50 in people with Advanced Solid Tumors, run by HighField Biopharmaceuticals Corporation at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xun Wang (+86-571-86961869, wangxun717416@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLT) (time frame: 28 days after the first dose (C1D1) for each dose cohort.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07601334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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