FK-PC101 for Prostate Cancer

Recruiting at 3 trial locations

Overseen By FK-PC101 Trial Management

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Cellvax Therapeutics Inc

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Active malignancy, Cardiovascular disease, Autoimmune disease, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer. It will also learn about the safety of FK-PC101. The main questions it aims to answer are: Does FK-PC101 delay or prevent the return of prostate cancer following surgery? What medical problems do participants (subjects) have when taking FK-PC101? Researchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor. Subjects will: Have a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body. This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer. If randomly selected to receive the vaccine, subjects will receive the vaccine up to 7 times over a 6-month period. In addition to the treatment visits for those randomized to receive FK-PC101, there will be up to 4 follow up visits to the clinic over a 22-month (nearly 2 year) period. For subjects randomized to receive current treatment practice, they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer. Should their prostate cancer return within a year following surgery, they will be eligible to receive FK-PC101, which already had been produced and thus no additional tumor tissue would need to be obtained. Subjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have received or plan to receive certain cancer therapies like radiation or hormone therapy before joining. It's best to discuss your specific medications with the trial team.

What makes the drug FK-PC101 unique for treating prostate cancer?

FK-PC101 is unique because it targets FKBP52, a protein involved in prostate cancer progression, and is designed for castration-resistant prostate cancer, which is a challenging form to treat. This drug is administered through intratumoral injections, which directly deliver the treatment to the tumor, potentially increasing its effectiveness compared to systemic treatments. ^{1 2 3 4 5}

Research Team

Fernando Kreutz, MD PhD

Principal Investigator

Cellvax Therapeutics Inc

Eligibility Criteria

Men with high-risk prostate cancer who've had surgery to remove their tumor can join. They must be healthy enough for regular visits, blood tests, and scans over nearly 2 years. Those with certain medical conditions or treatments that could interfere are excluded.

Inclusion Criteria

My recent scans show no signs of cancer spread far from the original site.

Has PSA >4 ng/mL ≤28 days prior to enrollment

My prostate cancer is classified as high-risk or very high-risk.

Exclusion Criteria

I do not have serious heart problems or recent major heart events.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 months

Treatment

Participants receive up to 7 doses of FK-PC101 vaccine over a 6-month period

6 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with up to 4 follow-up visits over a 22-month period

22 months

4 visits (in-person)

Control Group Monitoring

Participants in the control group are monitored with up to 8 visits over 22 months to track cancer recurrence

22 months

8 visits (in-person)

Treatment Details

Interventions

• FK-PC101 (Cancer Vaccine)

Trial Overview The trial is testing FK-PC101, a personalized vaccine made from the patient's own cancer tissue, against standard care. It aims to see if this vaccine can delay or prevent cancer return post-surgery. Participants will either receive the vaccine up to 7 times in 6 months or follow current treatment practices.

Participant Groups

Group I: FK-PC101 Experimental Treatment 1 Intervention

Up to 7 doses of intradermal FK-PC101 vaccine

Group II: Standard of Care Active Control 1 Intervention

Standard of care, with possibility to cross-over to FK-PC101 vaccine should prostate cancer recur within 1 year of radical prostatectomy

Who Is Running the Clinical Trial?

Cellvax Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

MJC13, a new drug targeting FKBP52, shows promise for treating castration-resistant prostate cancer, demonstrating significant tumor volume reduction in a mouse model after four weeks of treatment.

The optimal formulation of MJC13, which included PEG 400 and Tween 80, allowed for effective delivery and stability of the drug, achieving a concentration of 7.5 mg/mL for intratumoral injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solution formulation development and efficacy of MJC13 in a preclinical model of castration-resistant prostate cancer. Liang, S., Bian, X., Liang, D., et al.[2018]

The past decade has seen significant advancements in prostate cancer therapies, with multiple FDA approvals for new drugs, including poly (ADP-ribose) polymerase inhibitors (PARPi) like olaparib and rucaparib, which are effective against gene-mutated metastatic castration-resistant prostate cancer.

Androgen-targeted therapies such as apalutamide, darolutamide, and enzalutamide have shown superior efficacy in various stages of prostate cancer, including non-metastatic and metastatic forms, highlighting the evolution of treatment options beyond traditional androgen deprivation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Development and Future Prospects of Molecular Targeted Therapy in Prostate Cancer. Zhang, J., Sun, J., Bakht, S., et al.[2022]

New treatments for metastatic castrate-resistant prostate cancer (CRPC) are being developed, including drugs targeting the androgen receptor like abiraterone and MDV3100, which show promise in improving patient outcomes.

Cytotoxic chemotherapy with docetaxel has shown benefits for overall survival, but ongoing research is focused on enhancing these effects with new therapies, including bone-targeted treatments and immunotherapies, such as autologous vaccines and anti-CTLA4 antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drugs in metastatic castration-resistant prostate cancer]. Albiges, L., Loriot, Y., Gross-Goupil, M., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Solution formulation development and efficacy of MJC13 in a preclinical model of castration-resistant prostate cancer. [2018]

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

Identification and validation of novel androgen-regulated genes in prostate cancer. [2006]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Recent Development and Future Prospects of Molecular Targeted Therapy in Prostate Cancer. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[New drugs in metastatic castration-resistant prostate cancer]. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Increasing of FKBP9 can predict poor prognosis in patients with prostate cancer. [2020]