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New treatment option for Glioma
Official title A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma
ClinicalTrials.gov ID: NCT07678684
What this study is testing
What is HF1K16?
HF1K16 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Expected survival time of at least 3 months.
- Karnofsky Performance Status (KPS) score ≥ 60.
You likely can't join if
- Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy, with a daily prednisone dose \> 10 mg or...
- 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...
- 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...
See the full eligibility criteria
- 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).
- people of reproductive potential (including male people) 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...
- 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...
- 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...
- Any other active malignancy within 5 years prior to enrollment. people 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...
- Patients with hyperthyroidism are excluded. people with hypothyroidism on a stable dose of thyroid hormone replacement therapy with stable thyroid function (TSH ≤ 10 μIU/mL and no clinical manifestations of...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.