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

Sponsor
HighField Biopharmaceuticals Corporation
Study ID
NCT07678684
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HF1K16 — DRUG
    An investigational drug administered via intravenous (IV) infusion on specified days of a 28-day cycle.

Study Details

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.

Key Dates

First listed
Jul 1, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HF1K16 + Bevacizumab
    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.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Up to 2 years ]

Central Contacts

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