C5252 for Brain Cancer

Palo Alto (17 mi)

Overseen byRandy Jensen, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ImmVira Pharma Co. Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).

Eligibility Criteria

This trial is for adults over 18 with recurrent glioblastoma who've had 1-2 prior treatments. They must have a tumor size within specific limits, be in good physical condition (KPS ≥ 70), and expect to live more than 12 weeks. Participants need normal organ function and agree to use birth control. Excluded are those with certain medical conditions, CNS infections, increased steroids recently, immunosuppressive drugs within the last month, or active infections like hepatitis or COVID-19.

Inclusion Criteria

My cancer lesion is between 1.0 cm and 5.5 cm in size, confirmed by MRI.

My MRI shows my brain tumor is growing.

I am able to care for myself but may not be able to do active work.

My brain tumor has returned and is confirmed as glioblastoma.

I am 18 years old or older.

I understand and can follow the study's requirements.

My organs and bone marrow are functioning normally.

My condition worsened after 1 or 2 treatments.

Exclusion Criteria

I needed more steroids in the last 2 weeks before starting C5252.

I cannot stop my blood thinners for surgery or biopsy.

My brain tumor shows up on contrast imaging but doesn't fit the study requirements.

I don't have any serious illnesses or mental health issues that would stop me from following the study's requirements.

I need to keep taking medication for herpes virus.

I haven't taken immunosuppressive drugs in the last 28 days.

I am currently infected with COVID-19.

I have a history of brain infections or multiple sclerosis.

I have an active cold sore.

I have had an organ transplant.

I have no other cancers except possibly skin cancer or cervical cancer that hasn't spread.

I am allergic to certain virus-based therapies or immune system drugs.

I have Li-Fraumeni Syndrome or a genetic issue related to the retinoblastoma gene.

I do not have severe heart issues like recent heart attacks, unstable angina, or serious arrhythmias.

Treatment Details

The study tests C5252 given as a single injection directly into the tumor of patients with glioblastoma to assess its safety and tolerability. It's an early-stage trial (Phase 1) where everyone gets the same experimental treatment without any comparison group.

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

C5252 single agent dose escalation in participants with glioblastoma