Phase 2 trial launches of autologous prostate cancer vaccine

The first patient has been dosed in the phase 2 CELLVX-230 trial (NCT06636682), exploring the potential of the personalized immunotherapy FK-PC101 to delay or prevent prostate cancer recurrence following radical prostatectomy, Theragent announced in a news release.¹

In total, the trial plans to enroll 100 patients.

According to the company, FK-PC101 utilizes patients’ own tumor cells collected during surgery, which are then irradiated to make them incompetent for replication and delivered as an autologous cellular vaccine. Theragent recently produced the first batch of these agents, allowing for the first patient dosing in CellVax’s phase 2 trial.

"Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy," said CellVax CEO Fernando Kreutz in the news release.¹ "Further, after such recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT), both of which may lead to poorer health-related quality of life for patients. FK-PC101 could delay the necessity for such treatments, if not prevent them entirely."

The phase 2 CELLVX-230 trial is being conducted through a collaboration with the Society of Urologic Oncology Clinical Trials Consortium. The study’s principal investigator is Scott Eggener, MD, who is the vice chair of urology and director of the high risk and advanced prostate cancer clinic at theUniversity of Chicago in Illinois.

In total, the multicenter, adaptive trial plans to enroll 100 patients with high-risk prostate cancer following radical prostatectomy.² Participants will be enrolled across 3 clinical trial sites in the United States.

To be eligible for enrollment, patients need to have localized high-risk or very high-risk prostate cancer, no evidence of distant metastases, 3 or more prostate biopsy cores with at least 50% tumor involvement, a prostate-specific antigen level greater than 4 ng/mL within 28 days prior to enrollment, and a life expectancy of more than 5 years. Additionally, patients need to be a candidate for radical prostatectomy and have no prior history of nor plans to receive neoadjuvant radiation therapy, ADT, or any other anticancer therapy.

For the study, patients will be randomly assigned 1:1 to either the vaccine cohort or to a standard-of-care control cohort. Those assigned to receive the vaccine will receive up to 7 intradermal doses between day 1 and day 180. In both cohorts, BCG will be given concurrently with dose 1 (day 1) and dose 2 (day 8).

Upon disease recurrence, patients may be treated with other prostate cancer therapies that are deemed appropriate. Patients in the control group will be eligible to receive the vaccine following disease recurrence within 1 year of radical prostatectomy.

The primary outcome measure is disease-free survival, defined as free from local prostate cancer recurrence, distant metastatic prostate cancer recurrence, biochemical recurrence, or death from any cause. Secondary outcome measures include the time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety and tolerability. An additional outcome measure is overall survival. All end points will be assessed for up to 22 months.

Final completion of the CELLVX-230 trial is anticipated for May 2027.

References

1. Theragent and CellVax Therapeutics announce first manufacturing batch in phase 2 trial of FK-PC101, a novel personalized cancer immunotherapy. News release. Theragent. November 11, 2024. Accessed November 27, 2024. https://www.prnewswire.com/news-releases/theragent-and-cellvax-therapeutics-announce-first-patient-dosed-in-phase-2-trial-of-fk-pc101-a-novel-personalized-cancer-immunotherapy-302300746.html

2. FK-PC101 as adjuvant therapy for men with high-risk prostate cancer. ClinicalTrials.gov. Last updated October 21, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT06636682