About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
HF1K16
DrugAn investigational drug administered via intravenous (IV) infusion on specified days of a 28-day cycle.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Adverse Events
The number and percentage of participants experiencing adverse events (AEs), graded according to NCI-CTCAE v5.0
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.
Progression-Free Survival（PFS）
Time from the first dose to disease progression or death.
Secondary outcomes
The objective response rate(ORR)
Proportion of participants achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria.
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
Disease control rate (DCR)
Proportion of participants achieving CR, PR, or stable disease (SD) based on RECIST v1.1.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.