FK-PC101 for Prostate Cancer

Recruiting at 3 trial locations

Overseen By FK-PC101 Trial Management

Age: Any Age

Sex: Male

Trial Phase: Phase 2

Sponsor: Cellvax Therapeutics Inc

Must not be taking: Steroids, Immunosuppressants

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

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, FK-PC101, to determine if it can prevent prostate cancer from returning after surgery. Researchers aim to assess whether this vaccine is more effective than current treatments and if it is safe. Men who have undergone surgery for high-risk prostate cancer, with no signs of spreading, might be suitable for this study. Participants will either receive the vaccine or continue with standard care, undergoing regular tests and scans. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that FK-PC101 is likely to be safe for humans?

Research has shown that FK-PC101 was well-tolerated by patients in earlier studies. These studies found that this personalized vaccine was safe for men who underwent prostate cancer surgery. The vaccine targets specific cancer cells in the body to help prevent recurrence. While some individuals might experience side effects, no serious safety issues have been reported so far. The vaccine is made using the patient's own cancer cells, creating a unique treatment, which is promising for preventing cancer from returning. It is important to consult a doctor about any concerns to determine if joining the trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard of care for prostate cancer, which often involves surgery, radiation, or hormone therapy, FK-PC101 offers a new approach by using a vaccine strategy. This treatment is unique because it delivers up to seven doses of an intradermal vaccine aiming to stimulate the body’s immune system to specifically target and fight prostate cancer cells. Researchers are excited about FK-PC101 because it could potentially offer a more personalized treatment option with fewer side effects compared to traditional therapies. Additionally, the possibility for patients to cross over from standard care to this vaccine if cancer recurs adds an appealing safety net, potentially improving long-term outcomes.

What evidence suggests that FK-PC101 might be an effective treatment for prostate cancer?

Research has shown that FK-PC101, which participants in this trial may receive, may help reduce the chances of prostate cancer recurrence. Studies have found that this treatment can lower levels of prostate-specific antigen (PSA), often indicating cancer's return after surgery. FK-PC101 is a vaccine made from a patient's own cancer cells, enabling the immune system to identify and attack any remaining cancer cells. Early data suggest it is safe and might offer benefits, especially for those at high risk of cancer returning. Overall, FK-PC101 is considered an advanced treatment option to help prevent prostate cancer from returning after surgery. Participants in this trial may receive either FK-PC101 or standard care, with the possibility to switch to FK-PC101 if prostate cancer recurs within one year of radical prostatectomy. ^{1 2 3 5 6}

Who Is on the Research Team?

Fernando Kreutz, MD PhD

Principal Investigator

Cellvax Therapeutics Inc

Are You a Good Fit for This Trial?

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.

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

Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• FK-PC101

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

FKBP9 is expressed at higher levels in prostate cancer tissues compared to normal prostate tissues, indicating its potential role in cancer progression.

High levels of FKBP9 are associated with worse outcomes in prostate cancer, including lymph node and distant metastasis, and may serve as an independent predictor of patient survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing of FKBP9 can predict poor prognosis in patients with prostate cancer. Jiang, FN., Dai, LJ., Yang, SB., et al.[2020]

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]

A study identified 692 genes regulated by dihydrotestosterone in LNCaP prostate cancer cells, highlighting the role of androgen-regulated genes (ARGs) in both prostate development and cancer progression.

FKBP51 was found to be significantly overexpressed in prostate cancer compared to normal tissues, suggesting it could serve as a novel diagnostic marker or therapeutic target for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and validation of novel androgen-regulated genes in prostate cancer. Velasco, AM., Gillis, KA., Li, Y., et al.[2006]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40878915/

Reduced recurrence of prostate cancer with novel ... FK-PC101 demonstrated safety and potential clinical benefit in reducing prostate specific antigen (PSA) recurrence after RP in high-risk prostate cancer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06636682

FK-PC101 as Adjuvant Therapy for Men With High-Risk ... 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 ...

3. targetedonc.com targetedonc.com/view/novel-immunotherapy-fk-pc101-explored-in-prostate-cancer-trial

Novel immunotherapy FK-PC101 Explored in Prostate ... FK-PC101 is an advanced autologous cellular vaccine designed to help prevent recurrence in patients with prostate cancer who are at high risk after surgical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12407831/

PC101) post-prostatectomy: long-term results from a single ... FK-PC101 demonstrated safety and potential clinical benefit in reducing prostate specific antigen (PSA) recurrence after RP in high-risk prostate cancer ...

5. urologytimes.com urologytimes.com/view/fda-grants-clearance-to-ind-application-for-prostate-cancer-immunotherapy

FDA grants clearance to IND application for prostate ... Additional data on FK-PC101​​ The phase 1 study demonstrated initial safety and positive immune cellular response of the therapy in patients with ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=89c33721-9d73-4eca-952c-b9cee6a93ce9

FK-PC101 / CellVax Therap, FK Biotec - "FK-PC101 demonstrated safety and potential clinical benefit in reducing prostate ... FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer ...