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

NCT07678684 | Recruiting Phase 2 DMC

• 1 other identifier: HF1K16-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult; Glioma

Keywords

Drug Combinations; Drug Safety; Drug Tolerance

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events

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

  Up to 2 years

• 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.

  Up to 2 years

• Progression-Free Survival（PFS）

  Time from the first dose to disease progression or death.

  Up to 2 years

Secondary Outcomes (5)

• The objective response rate(ORR)

  Up to 2 years

• Time-To-Next-Intervention (TTNI)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

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

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

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

HF1K16 + Bevacizumab

EXPERIMENTAL

This 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.

Drug: HF1K16

Interventions

HF1K16 DRUG

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

HF1K16 + Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• HighField Biopharmaceuticals Corporation: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

xun Wang

CONTACT

+86-571-86961869; wangxun21@hf-biopharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)