C5252 for Brain Cancer

Recruiting at 1 trial location

Overseen By ImmVira Pharma Co., LTD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ImmVira Pharma Co. Ltd

Must not be taking: Immunosuppressants, Anticoagulants, Antiplatelets, HSV drugs

Disqualifiers: Encephalitis, Multiple sclerosis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

51 Participants Needed

What You Need to Know Before You Apply

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).

Will I have to stop taking my current medications?

The trial requires that you do not take immunosuppressive agents within 28 days before the treatment and you cannot be on drugs active against HSV. You also need to stop anticoagulants or antiplatelet agents if they can't be paused for surgery or biopsy.

How does the drug C5252 differ from other brain cancer treatments?

C5252 is unique because it targets specific molecular pathways involved in brain cancer, such as the PI3K/Akt/mTOR pathway, which is often dysregulated in these tumors. This drug's ability to cross the blood-brain barrier and inhibit both p70S6K and Akt makes it a promising option for treating brain cancers with central nervous system involvement. ^{1 2 3 4 5}

Who Is on the Research Team?

Randy Jensen, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

C5252 single agent dose escalation in participants with glioblastoma to evaluate safety and determine the recommended dose

4 weeks

Multiple visits for dose administration and monitoring

Dose Expansion

Recommended dose of C5252 as determined in Part 1 Dose Escalation to further assess safety, tolerability, and preliminary efficacy

4 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Regular follow-up visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

• C5252

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

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

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

C5252 single agent dose escalation in participants with glioblastoma

Who Is Running the Clinical Trial?

ImmVira Pharma Co. Ltd

Lead Sponsor

Trials

6

Recruited

530+

Published Research Related to This Trial

Recent advancements in molecular techniques have identified actionable alterations in rare CNS tumors, leading to potential targeted therapies that can improve neurological symptoms and quality of life.

Specific treatments targeting pathways like mTOR in SEGAs and BRAF V600E mutations in certain glial and glioneuronal tumors show promise, highlighting the importance of personalized medicine in managing these challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Therapies in Rare Brain Tumours. Bruno, F., Pellerino, A., Bertero, L., et al.[2021]

The combination of sorafenib and lapatinib was found to work synergistically to kill various CNS tumor cells, including those resistant to lapatinib, suggesting a promising treatment strategy for glioblastoma.

This drug combination not only enhanced the effectiveness of radiation therapy but also altered cellular mechanisms related to autophagy, indicating a complex interaction that could be leveraged for improved cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sorafenib/regorafenib and lapatinib interact to kill CNS tumor cells. Hamed, HA., Tavallai, S., Grant, S., et al.[2021]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Therapies in Rare Brain Tumours. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

M2698 is a potent dual-inhibitor of p70S6K and Akt that affects tumor growth in mouse models of cancer and crosses the blood-brain barrier. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Molecular neuro-oncology and the development of targeted therapeutic strategies for brain tumors. Part 5: apoptosis and cell cycle. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Current Challenges and Opportunities in Treating Glioblastoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sorafenib/regorafenib and lapatinib interact to kill CNS tumor cells. [2021]