9 Participants Needed

Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody for Breast Cancer

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

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of CF33-hNIS-antiPDL1 in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is designed to infect tumor cells and break them down.

Will I have to stop taking my current medications?

The trial requires that you stop chemotherapy, biological therapy, immunotherapy, or investigational therapy at least 14 days before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment CF33-hNIS-antiPDL1 for breast cancer?

The treatment CF33-hNIS-antiPDL1 has shown promise in preclinical studies for triple-negative breast cancer, where it demonstrated anti-tumor effects in mice without causing harmful side effects. Additionally, similar treatments have been effective in enhancing immune responses against other cancers, like pancreatic and gastric cancer, suggesting potential benefits for breast cancer as well.12345

Is the treatment CF33-hNIS-antiPDL1 generally safe for humans?

Anti-PD-1 and anti-PD-L1 antibodies, which are part of the CF33-hNIS-antiPDL1 treatment, are generally well tolerated and safe when used alone or in combination with other therapies in various cancers, including breast cancer.678910

What makes the treatment CF33-hNIS-antiPDL1 unique for breast cancer?

CF33-hNIS-antiPDL1 is unique because it uses a genetically modified virus to directly attack cancer cells and boost the immune system's response by blocking PD-L1, a protein that helps cancer cells hide from immune attacks. This approach is particularly novel for triple-negative breast cancer, which is typically hard to treat with standard therapies.12345

Research Team

JR

Jamie Rand

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with metastatic triple negative breast cancer who have tried at least two treatments without success. Participants must not be pregnant, breastfeeding, or have other cancers; they should also agree to use birth control and provide biopsies. They need normal blood counts, liver function within certain limits, and cannot join if they've had recent vaccines or infections.

Inclusion Criteria

I have recovered from major side effects of my previous cancer treatment.
My breast cancer is triple negative and has spread to other parts.
Documented informed consent of the participant and/or legally authorized representative
See 14 more

Exclusion Criteria

I am currently taking antibiotics for an infection.
Inability to comply with study procedures
I do not have any uncontrolled serious illnesses.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive CF33-hNIS-antiPDL1 intratumorally on days 1 and 15, repeating every 28 days for up to 3 cycles

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year
1 visit at 30 days, then every 3 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 3 years

Treatment Details

Interventions

  • CF33-hNIS-antiPDL1
Trial OverviewThe trial tests CF33-hNIS-antiPDL1, an oncolytic virus designed to infect and break down tumor cells in patients with advanced breast cancer. It's a phase I study focusing on the safety of this treatment and finding the right dosage.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (CF33-hNIS-antiPDL1)Experimental Treatment1 Intervention
Patients receive CF33-hNIS-antiPDL1 IT on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

Imugene Limited

Industry Sponsor

Trials
7
Recruited
340+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.
Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies.Naidoo, J., Page, DB., Li, BT., et al.[2023]
Anti-PD-1 and anti-PD-L1 antibodies show modest response rates as standalone treatments for metastatic breast cancer, but they are generally well tolerated and can provide significant, lasting benefits for some patients.
These antibodies can be safely combined with various systemic therapies, including chemotherapy and targeted therapies, as well as radiotherapy, suggesting potential for enhanced effectiveness in treating metastatic breast cancer.
Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer.Page, DB., Bear, H., Prabhakaran, S., et al.[2023]

References

A comprehensive preclinical study supporting clinical trial of oncolytic chimeric poxvirus CF33-hNIS-anti-PD-L1 to treat breast cancer. [2022]
CF33-hNIS-antiPDL1 virus primes pancreatic ductal adenocarcinoma for enhanced anti-PD-L1 therapy. [2023]
Anti-Tumor Immunogenicity of the Oncolytic Virus CF33-hNIS-antiPDL1 against Ex Vivo Peritoneal Cells from Gastric Cancer Patients. [2023]
Oncolytic poxvirus CF33-hNIS-ΔF14.5 favorably modulates tumor immune microenvironment and works synergistically with anti-PD-L1 antibody in a triple-negative breast cancer model. [2022]
Development of the oncolytic virus, CF33, and its derivatives for peritoneal-directed treatment of gastric cancer peritoneal metastases. [2023]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
MOVIE: a phase I, open-label, multicenter study to evaluate the safety and tolerability of metronomic vinorelbine combined with durvalumab plus tremelimumab in patients with advanced solid tumors. [2023]
Hyperresponsiveness to interferon gamma exposure as a response mechanism to anti-PD-1 therapy in microsatellite instability colorectal cancer. [2019]
Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer. [2023]
Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study. [2022]