AzTrials
AzTrials

GliomaPhase 2NCT07678684

A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma

A Phase 2 study testing HF1K16 in people with Glioma and Adult, run by HighField Biopharmaceuticals Corporation at 1 site 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
Search all trials

Trial summary

The primary purpose of this Phase II study is to evaluate the preliminary anti-tumor efficacy of HF1K16 in combination with Bevacizumab in patients with recurrent or progressive glioma. The study also evaluates the safety and tolerability of the combination therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioma, Adult
What is being tested?
HF1K16
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 Jun 2026to 31 Dec 2028
Phase
Phase 2
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

  • The patient and/or guardian must voluntarily sign and date a written informed consent form.
  • Age ≥ 18 years and ≤ 75 years at the time of informed consent signing, male or female.
  • Confirmed diagnosis of glioma by histopathology and molecular pathology, with recurrent or progressive disease following prior therapy, and no available standard treatment or intolerance to standard treatment.
  • Expected survival time of at least 3 months.
  • Karnofsky Performance Status (KPS) score ≥ 60.
  • Adequate organ and bone marrow function as defined by the following criteria:
Show all 13Show fewer
  • Bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 90×10⁹/L, and hemoglobin ≥ 9.0 g/dL (without transfusion or hematopoietic growth factor support within 14 days);
  • Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and international normalized ratio (INR) ≤ 1.5×ULN;
  • Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; in the presence of liver metastases, ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN;
  • Renal function: creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • QTcF interval on electrocardiogram < 450 ms (males) or < 470 ms (females).
  • Subjects of reproductive potential (including male subjects) must agree to avoid pregnancy and use effective contraceptive measures with their partners during the study period and for 6 months after the last dose. A negative serum pregnancy test must be confirmed between screening and prior to the first dose.

Who cannot join

  • Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy, with a daily prednisone dose > 10 mg or equivalent corticosteroid within 2 weeks prior to study treatment.
  • Uncontrolled seizures, hypertension, or psychiatric disorder at screening.
  • Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complicated infection requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose, except for antiviral therapy for hepatitis B or hepatitis C.
  • Third-space effusion that cannot be effectively controlled by drainage or other measures.
  • Participation in another clinical trial of an investigational drug within 4 weeks prior to enrollment.
  • Receipt of any anti-tumor therapy including chemotherapy, targeted therapy, biologic therapy, immunotherapy, radical radiotherapy, or major surgery within 2 weeks prior to enrollment or within 3 half-lives (whichever is shorter).
Show all 12Show fewer
  • Any other active malignancy within 5 years prior to enrollment. Subjects with other malignancies cured by local therapy (e.g., basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix) are excepted.
  • Patients with hyperthyroidism are excluded. Subjects with hypothyroidism on a stable dose of thyroid hormone replacement therapy with stable thyroid function (TSH ≤ 10 μIU/mL and no clinical manifestations of hypothyroidism) may be enrolled.
  • Failure to recover from all adverse events due to prior therapy to Grade ≤ 1 (per CTCAE v5.0) or to baseline levels, except for toxicities deemed by the investigator to pose no safety risk (such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).
  • Any active cardiac disease within 6 months prior to the first dose, including New York Heart Association (NYHA) Class II-IV cardiac dysfunction, congestive heart failure, myocardial infarction, unstable angina, and/or stroke or other cardiovascular or cerebrovascular events of Grade 3 or higher, or left ventricular ejection fraction (LVEF) < 50%.
  • HIV infection, active HBV infection (HBV DNA above the upper limit of normal), or active HCV infection (HCV RNA above the upper limit of normal).
  • Any other serious systemic disease or any other condition that, in the opinion of the investigator, would render the subject ineligible for participation in this clinical study.

Trial locations and contacts

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

xun Wang contact

+86-571-86961869

wangxun21@hf-biopharm.com

China1 site, 1 recruiting

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Ruofan Huang, huangruofan@huashan.org.cn

    Jinsong Wu, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Adaptive Phase Ⅱ Clinical Study of HF1K16 Combined With Bevacizumab in Recurrent or Progressive Glioma

The primary purpose of this Phase II study is to evaluate the preliminary anti-tumor efficacy of HF1K16 in combination with Bevacizumab in patients with recurrent or progressive glioma. The study also evaluates the safety and tolerability of the combination therapy.

Read the detailed description

This multicenter, open-label, adaptive Phase II study evaluates the combination of HF1K16 and Bevacizumab in recurrent or progressive glioma. HF1K16 combines a lipid bilayer structure with all-trans retinoic acid (ATRA). In glioma patients, myeloid-derived suppressor cells (MDSCs) typically accumulate and exert strong immunosuppressive activity. HF1K16 is designed to induce immature MDSCs to differentiate into mature, active immune cells, thereby reversing immune suppression in the tumor microenvironment. The combination of HF1K16 and Bevacizumab is expected to achieve a synergistic anti-tumor effect by simultaneously inhibiting angiogenesis and remodeling the immunosuppressive tumor microenvironment to maximize efficacy.

Conditions
Glioma, Adult
Being tested
HF1K16
Keywords
Drug Combinations, Drug Safety, Drug Tolerance
Medical subject headings
Glioma

What participants receive

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

  • HF1K16Drug

    An investigational drug administered via intravenous (IV) infusion on specified days of a 28-day cycle.

Study groups in NCT07678684
Study groupRoleWhat they receive
HF1K16 + BevacizumabExperimentalThis study includes a dose-escalation phase followed by an adaptive expansion phase. Participants will receive combination therapy of HF1K16 (at 3 planned dose levels during escalation) and Bevacizumab to evaluate preliminary efficacy and safety.
Receives: Drug: HF1K16

What is being measured

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

  1. Incidence of Adverse Events

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

    Measured: Up to 2 years

  2. The recommended Phase II dose

    The RP2D will be determined via dose escalation, and efficacy evaluation will be conducted at the RP2D across different tumor types during the expansion phase.

    Measured: Up to 2 years

  3. Progression-Free Survival（PFS）

    Time from the first dose to disease progression or death.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. The 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. Time-To-Next-Intervention (TTNI)

    The time from the date of the first dose of study treatment to the date of initiation of the first subsequent anti-cancer therapy or intervention

    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. Change from Baseline in the Quantity of Myeloid-derived suppressor cells（MDSC）

    Evaluated by measuring the percentage or absolute counts of MDSCs in peripheral blood samples collected from participants before and after treatment.

    Measured: Baseline, and at designated time points during treatment up to 2 years

  5. 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.

  1. First posted1 Jul 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07678684
Sponsor's protocol ID
HF1K16-201
Status last verified
May 2026
First submitted
7 Jun 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HF1K16 in people with Glioma and Adult, 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 13 inclusion and 12 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 10 Jul 2026. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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, wangxun21@hf-biopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Up to 2 years). 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 NCT07678684.

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 10 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in