C5252 for Brain Cancer

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, C5252, for brain cancer, specifically recurrent or worsening glioblastoma. The focus is on determining its safety and patient tolerance when injected directly into the tumor. The trial consists of two parts: first, testing various doses to identify the optimal amount, and then assessing the effectiveness of that dose. It seeks participants who have undergone at least one prior treatment for glioblastoma and show evidence of tumor progression on an MRI. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that C5252 is likely to be safe for humans?

Research has shown that C5252 appears safe in early studies. In lab and animal tests, C5252 proved both safe and effective in treating glioblastoma, a type of brain cancer. Other findings suggest that people tolerate the treatment well, with no serious side effects reported so far. These early results are promising, but further research is needed to fully understand the safety of C5252 in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glioblastoma, which often include surgery, radiation, and chemotherapy, C5252 is unique because it is a single-agent therapy designed specifically for dose escalation. Researchers are excited about C5252 because it targets glioblastoma with a novel approach that may enhance its effectiveness and safety profile compared to existing options. This treatment focuses on finding the optimal dose that maximizes efficacy while minimizing side effects, potentially offering a more precise and personalized treatment option for patients with this aggressive type of brain cancer.

What evidence suggests that C5252 might be an effective treatment for brain cancer?

Research has shown that C5252 may help treat glioblastoma, a type of brain cancer. In studies with mice, C5252 slowed tumor growth and extended the mice's lifespan. This trial will evaluate C5252 in two parts: Part 1 involves dose escalation to determine the appropriate dosage, and Part 2 will expand on this to further assess its effects. Early findings indicate that C5252 is safe and well-tolerated, and it might help the body's immune system fight the tumor. Although information about its effects in humans remains limited, these early results are promising. ^{1 2 4 5 6}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11053222/

Enhanced therapeutic efficacy for glioblastoma ... C5252 treatment significantly inhibited the progression of GBM and prolonged the survival of the tumor-bearing mice (Figure 5D). The anti-tumor activity was ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06126744

NCT06126744 | Open-Label Study to Evaluate the Safety, ... This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10134201/

Immunotherapy in glioblastoma treatment: Current state and ... The results demonstrated that the administration of CAR-Ts Cells by infusion is a safe route to be used, as there was no evidence of toxicity ...

4. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT056/761331/Abstract-CT056-A-phase-1-study-of-intratumoral

Abstract CT056: A phase 1 study of intratumoral HSV1 co ... Preliminary findings indicate MVR-C5252 delivered via CED is safe and well-tolerated in recurrent HGG, with early immune activation suggesting ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05095441

NCT05095441 | A Clinical Study of Intratumoral MVR- ... 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) ...

6. immviragroup.com immviragroup.com/news/555.html

ImmVira's MVR-C5252 Targeting Brain Tumor Obtained US ... 8, 2021 /PRNewswire/ -- ImmVira announces MVR-C5252 targeting Glioblastoma has received the U.S. FDA clearance to proceed with clinical trial on August 6, 2021.