A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer

Clinical Trial Details

This is a multi-center Phase 1/2 clinical trial to evaluate the safety, prostate-specific antigen (PSA) response, and immunogenicity of the VTP850 prime-boost immunotherapeutic in men with biochemical recurrence of prostate cancer after definitive local therapy.

VTP-850 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration.

VTP-850 consists of 2 components: ChAdOx1-PCAQ and MVA-PCAQ. All participants will receive ChAdOx1-PCAQ on Day 1 and MVA-PCAQ on Days 29 and 57.

Participants will be followed for 6 months or until the start of new therapy, such as Androgen Deprivation Therapy (ADT), or until disease progression. Participants who have a PSA response, defined as greater than a 50% reduction in serum PSA compared to baseline at any time, measured twice consecutively, at least 2 weeks apart during the 6-month follow-up, will be followed for an additional 18 months.

Phase 1 will follow a 3+3 design to determine the recommended regimen that will be used in Phase 2.

Phase 2 will consist of 2 sequential stages. In Stage 1 of Phase 2, additional participants will be enrolled at the chosen Phase 2 regimen. If 4 or more of the 25 participants at the phase 2 dose regiment have a PSA response, Stage 2 will be opened to enrollment of up to 100 additional participants.

The total length of study participation depends on which phase each participant is in and will be discussed with the study team.

Key Eligibility:

Inclusion Criteria:

Males aged 18 years and older
A confirmed diagnosis of prostate cancer
Has undergone primary therapy for prostate cancer (radical prostatectomy and/or definitive external beam radiation and/or brachytherapy).
No further local therapy to the prostate and no metastasis-directed therapy for PSA-positron emission tomography (PET) positive lesions planned within 4 months after the first dose of VTP-850.

Exclusion Criteria:

Any other prior malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Unstable medical condition, drug or alcohol abuse, or medical or psychiatric condition that in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the trial requirements.
Significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrinological, hematological or neurological disorders constituting a risk when taking the trial intervention or interfering with the interpretation of data; cardiac event or heart failure in the previous 6 months.

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

646-962-2072
guonc@med.cornell.edu

Primary Investigator(s)

Cora Sternberg, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2305026022

ClinicalTrials.gov:

NCT05617040

Status

Open to Enrollment

Age Group

Adult

Disease

Prostate Cancer