A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor
ConditionGlioma, Malignant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmVira Pharma Co. Ltd
About this trial
This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Confirmed recurrent malignant high-grade (WHO grade 3-4) glioma who have received standard therapy and no available treatment.
Measurable lesions exist in accordance with RANO criteria.
Sufficient space for ≥1 mL drug infused into tumor cavity post resection.
Disqualifiers
Inability to undergo MRI examination for any reason.
Active hemorrhage observed before enrollment.
Imaging test: a. lesion located in non-cerebral regions; b. there are other lesions outside target tumor cavity; c. extra-cranial metastasis.
Tumor lesion locates in ventricular system or there is a clear perforation between the tumor cavity and the ventricle after tumor resection.
Trial design
Design model
Single group
Treatments tested in this trial
Herpes Virus C5252 Injection
Biological/VaccineC5252 will be administered at designed dose level.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Herpes Virus C5252 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase I: Incidence of adverse event
TEAE, SAE, DLT, AESI during treatment period
Time frame
Up to 30 days after completion of treatment2
Phase I: Determine the MTD/RP2D
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
Time frame
up to 4 weeks3
Phase II: Overall Survival
The overall survival for each patient receiving C5252 will be calculated.
Time frame
Up to 2 years4
Phase II: OS rate
OS rate at 6, 12, 18 and 24 months after first study dose
Time frame
Up to 2 years after first doseSponsors and contacts
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Source ClinicalTrials.gov