Advanced Solid TumorsEarly Phase 1HF50NCT06822998
HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
A Early Phase 1 study testing HF50 in people with Advanced Solid Tumors, run by HighField Biopharmaceuticals Corporation at 1 site in China.
Trial summary
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HF50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2025to 1 Jun 2026
- Phase
- Early 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must voluntarily provide written informed consent (ICF) prior to any study-related procedures, and be capable of complying with all protocol requirements.
- Adult participants aged between 18 and 75 years (inclusive) at the time of ICF signing.
- Histologically or cytologically confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, or have relapsed after standard therapies, are intolerant to standard therapies (e.g., chemotherapy, targeted therapy), or lack effective treatment options.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- At least one measurable lesion as defined by RECIST version 1.1.
- Adequate organ and bone marrow function as demonstrated by the following laboratory parameters:Hematologic Function:Absolute neutrophil count (ANC) ≥1.5×10⁹/L、Lymphocyte count ≥1.0×10⁹/L、Platelet count ≥90×10⁹/L、Hemoglobin ≥9.0 g/dL (without transfusion or erythropoietin-stimulating agents within 14 days)； Coagulation Parameters:Activated partial thromboplastin time (aPTT) ≤1.5×ULN、 International normalized ratio (INR) ≤1.5. Hepatic Function:Total bilirubin (TBIL) ≤1.5×ULN、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for participants with liver metastases, and TBIL ≤3×ULN)； Renal Function:Creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula).
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose. Male and female participants of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
Who cannot join
- History of active autoimmune disease or autoimmune disease considered unsuitable for study participation, with exceptions for localized skin conditions (e.g., eczema involving <10% of body surface area, vitiligo, psoriasis, alopecia) or childhood asthma resolved without treatment in adulthood.
- Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose, except for local steroid use.
- Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy less than 2 weeks (or 4 weeks for nitrosourea or mitomycin C) or within 5 half-lives of the prior therapy before the first dose.
- Symptomatic brain metastases or leptomeningeal disease unless adequately treated (e.g., surgery or radiotherapy) with no evidence of progression for ≥28 days and off systemic steroids for ≥14 days prior to the first dose.
- Unresolved toxicities from prior therapies ≥Grade 2 (CTCAE v5.0) at baseline, except for toxicities deemed by the investigator to pose no safety risk (e.g., alopecia, stable hypothyroidism with hormone replacement).
- Significant cardiovascular or cerebrovascular conditions, including but not limited to:Thromboembolic events requiring therapeutic anticoagulation within 3 months prior to the first dose.NYHA Class III or IV heart failure.Acute coronary syndrome, congestive heart failure, aortic dissection, or stroke within 6 months prior to the first dose.Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), unless controlled with antihypertensive medication.
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- Active infection or unexplained fever >38.5°C within 1 week prior to the first dose (tumor-related fever may be eligible at the investigator's discretion).
- Known HIV infection, active hepatitis B virus (HBV) infection (HBV DNA >ULN), or active hepatitis C virus (HCV) infection (HCV RNA >ULN).
- Gastrointestinal symptoms or other conditions requiring intervention within 4 weeks prior to the first dose that would, in the investigator's judgment, impair study participation.
- Pregnant or breastfeeding women.
- Any other severe systemic disease, psychological condition, or significant clinical abnormality deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Zelei Dai, +86 176 9116 1216, daisydzl@163.com
About this study
Official title: An Open-label, Single-arm, Non-randomized, Single-center, Dose-escalation Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of HF50 in Subjects With HER-2 Positive and HER-2 Low-expression Advanced Solid Tumors
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
- Conditions
- Advanced Solid Tumors
- 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 a liposomal T-cell engager with an unique design based on the lipid bilayer. It was also named a T cell Redirecting Antibody Fragment-anchored Liposomes (TRAFsome). The liposomal surface carries anti-CD3ε and anti-HER2 antibody-conjugated lipid molecules, enabling T-cell redirection and activation at HER2-positive or HER2-low tumor sites. In addition, the liposome internal space contains a TLR7/8 agonist Resiquimod (R848), which has been shown to help modulate the myeloid cells in the tumor micro-environement to complement the immune activation effects.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 - 1 mg | Experimental | Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 1 mg, with a lead-in dose on Cycle 1 Day 1 (C1D1) followed by the target dose on C1D8, C1D15, and C1D22. Receives: Drug: HF50 |
| Dose Level 2 - 10 mg | Experimental | Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 10 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. Receives: Drug: HF50 |
| Dose Level 3 - 60 mg | Experimental | Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 60 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. Receives: Drug: HF50 |
| Dose Level 4 - 240 mg | Experimental | Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 240 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. Receives: Drug: HF50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Incidence of Serious Adverse Events (SAEs)
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.
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)
Incidence of Vital Sign Abnormalities
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline vital sign abnormality, including blood pressure, heart rate, respiratory rate, and body temperature. Grades are defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From first dose to the end of the study (assessed up to 1 year)
Laboratory Abnormalities
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including hematology (complete blood count), blood chemistry, urinalysis, coagulation function, and C-reactive protein (CRP). Grades are defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From first dose to the end of the study (assessed up to 1 year)
Incidence of Electrocardiogram (ECG) Abnormalities
Number of participants who experienced an abnormal ECG finding post-baseline, including clinically significant changes in QT interval, PR interval, QRS duration, or other rhythm abnormalities as assessed by 12-lead ECG. Abnormalities will be graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From first dose to the end of the study (assessed up to 1 year)
Incidence of Echocardiography (ECHO) Abnormalities
Number of participants who experienced an abnormal echocardiography finding post-baseline, including changes in left ventricular ejection fraction (LVEF), chamber size abnormalities, or valvular dysfunction. Abnormalities will be graded according to CTCAE v5.0.
Measured: From first dose to the end of the study (assessed up to 1 year)
Secondary outcomes (9)
Pharmacokinetic Parameter - Cmax
Maximum plasma concentration (Cmax) of HF50 will be assessed following single and multiple dosing.
Measured: Up to 9 weeks
Pharmacokinetic Parameter - Tmax
Time to maximum plasma concentration (Tmax) of HF50 will be assessed following single and multiple dosing.
Measured: Up to 9 weeks
Pharmacokinetic Parameter - AUC (Area Under the Curve)
AUC0-t and AUC0-inf will be evaluated to determine systemic exposure to HF50.
Measured: Up to 9 weeks
Pharmacokinetic Parameter - Half-life (t1/2)
The terminal elimination half-life (t1/2) of HF50 will be calculated.
Measured: Up to 9 weeks
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
Duration of Response (DOR)
Time from the first documented response (CR or PR) to disease progression or death.
Measured: Up to 2 years
Disease Control Rate (DCR)
Proportion of participants achieving CR, PR, or stable disease (SD) based on RECIST v1.1.
Measured: Up to 2 years
Progression-Free Survival (PFS)
Time from the first dose to disease progression or death.
Measured: Up to 2 years
Overall Survival (OS)
Time from the first dose to death from any cause.
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.
- First posted12 Feb 2025
- Study start11 Jun 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighField Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Liu, MD, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822998
- Sponsor's protocol ID
- HF50-101
- Acronym
- HF50
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Non-randomized, Single-center, Dose-escalation Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of HF50 in Subjects With HER-2 Positive and HER-2 Low-expression Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06822998
- Acronym / sponsor ID
- HF50 / HF50-101
- Conditions
- Advanced Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HighField Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 - 1 mg | Experimental | Drug: HF50Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 1 mg, with a lead-in dose on Cycle 1 Day 1 (C1D1) followed by the target dose on C1D8, C1D15, and C1D22. |
| Dose Level 2 - 10 mg | Experimental | Drug: HF50Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 10 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. |
| Dose Level 3 - 60 mg | Experimental | Drug: HF50Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 60 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. |
| Dose Level 4 - 240 mg | Experimental | Drug: HF50Participants in this arm will receive HF50 via intravenous infusion once weekly for 3 weeks in a 3-week treatment cycle. The dose is 240 mg, with a lead-in dose on C1D1 followed by the target dose on C1D8, C1D15, and C1D22. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must voluntarily provide written informed consent (ICF) prior to any study-related procedures, and be capable of complying with all protocol requirements.
- Adult participants aged between 18 and 75 years (inclusive) at the time of ICF signing.
- Histologically or cytologically confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, or have relapsed after standard therapies, are intolerant to standard therapies (e.g., chemotherapy, targeted therapy), or lack effective treatment options.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
Key exclusion criteria (11 listed)
- History of active autoimmune disease or autoimmune disease considered unsuitable for study participation, with exceptions for localized skin conditions (e.g., eczema involving <10% of body surface area, vitiligo, psoriasis, alopecia) or childhood asthma resolved without treatment in adulthood.
- Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose, except for local steroid use.
- Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy less than 2 weeks (or 4 weeks for nitrosourea or mitomycin C) or within 5 half-lives of the prior therapy before the first dose.
- Symptomatic brain metastases or leptomeningeal disease unless adequately treated (e.g., surgery or radiotherapy) with no evidence of progression for ≥28 days and off systemic steroids for ≥14 days prior to the first dose.
- Unresolved toxicities from prior therapies ≥Grade 2 (CTCAE v5.0) at baseline, except for toxicities deemed by the investigator to pose no safety risk (e.g., alopecia, stable hypothyroidism with hormone replacement).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF50HF50 is a liposomal T-cell engager with an unique design based on the lipid bilayer. It was also named a T cell Redirecting Antibody Fragment-anchored Liposomes (TRAFsome). The liposomal surface carries anti-CD3ε and anti-HER2 antibody-conjugated lipid molecules, enabling T-cell redirection and activation at HER2-positive or HER2-low tumor sites. In addition, the liposome internal space contains a TLR7/8 agonist Resiquimod (R848), which has been shown to help modulate the myeloid cells in the tumor micro-environement to complement the immune activation effects. | Drug | Dose Level 1 - 1 mg, Dose Level 2 - 10 mg, Dose Level 3 - 60 mg, Dose Level 4 - 240 mg |
Primary outcome
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).
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
Incidence of Serious Adverse Events (SAEs)
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.
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.
Incidence of Vital Sign Abnormalities
Time frame: From first dose to the end of the study (assessed up to 1 year)
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline vital sign abnormality, including blood pressure, heart rate, respiratory rate, and body temperature. Grades are defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Laboratory Abnormalities
Time frame: From first dose to the end of the study (assessed up to 1 year)
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including hematology (complete blood count), blood chemistry, urinalysis, coagulation function, and C-reactive protein (CRP). Grades are defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Incidence of Electrocardiogram (ECG) Abnormalities
Time frame: From first dose to the end of the study (assessed up to 1 year)
Number of participants who experienced an abnormal ECG finding post-baseline, including clinically significant changes in QT interval, PR interval, QRS duration, or other rhythm abnormalities as assessed by 12-lead ECG. Abnormalities will be graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Incidence of Echocardiography (ECHO) Abnormalities
Time frame: From first dose to the end of the study (assessed up to 1 year)
Number of participants who experienced an abnormal echocardiography finding post-baseline, including changes in left ventricular ejection fraction (LVEF), chamber size abnormalities, or valvular dysfunction. Abnormalities will be graded according to CTCAE v5.0.
9 secondary outcomes
Pharmacokinetic Parameter - Cmax
Time frame: Up to 9 weeks
Pharmacokinetic Parameter - Tmax
Time frame: Up to 9 weeks
Pharmacokinetic Parameter - AUC (Area Under the Curve)
Time frame: Up to 9 weeks
Pharmacokinetic Parameter - Half-life (t1/2)
Time frame: Up to 9 weeks
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Liu, MD, PhD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HF50 in people with Advanced Solid Tumors, run by HighField Biopharmaceuticals Corporation at 1 site 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 8 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 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zelei Dai, MMedSc (+86 17691161216, daisydzl@icloud.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 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.