The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.

NCT05010200 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: Study 20-02159PRMC 20-027
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

  Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .

  37 days

• Number of adverse events

  Adverse events will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v5.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale .

  191 days

Secondary Outcomes (7)

• Change in immune cell subsets

  37 days

• Change in immune cell subsets

  191 days

• Change in immune cell subsets

  365 days

• Change in the frequency of vaccine epitope-specific T lymphocyte populations

  37 days

• Change in the frequency of vaccine epitope-specific T lymphocyte populations

  191 days

Study Arms (3)

Cohort 1 - Primary treatment cohort

EXPERIMENTAL

Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC.

Biological: PGV-001; Biological: Poly-ICLC

Cohort 2 - Secondary treatment cohort

EXPERIMENTAL

Patients receive the personalized genomic vaccine (PGV) and Poly-ICLC, and CDX-301

Biological: PGV-001; Biological: Poly-ICLC; Biological: CDX-301

Cohort 3 - Expansion treatment cohort

EXPERIMENTAL

An expansion cohort if the treatment of all 3 together has not triggered a safety stopping event.

Biological: PGV-001; Biological: Poly-ICLC; Biological: CDX-301

Interventions

PGV-001 BIOLOGICAL

personalized genomic peptide vaccine

Cohort 1 - Primary treatment cohort; Cohort 2 - Secondary treatment cohort; Cohort 3 - Expansion treatment cohort

Poly-ICLC BIOLOGICAL

immune modulator

Cohort 1 - Primary treatment cohort; Cohort 2 - Secondary treatment cohort; Cohort 3 - Expansion treatment cohort

CDX-301 BIOLOGICAL

soluble recombinant human protein to work on stem cell

Cohort 2 - Secondary treatment cohort; Cohort 3 - Expansion treatment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be enrolled a subject must meet the following criteria:
• The subject must have a histologically proven diagnosis of adenocarcinoma of prostate
• The subject should have any one of:
• PSA persistence post surgery (defined as a PSA value that fails to become undetectable) by six weeks post treatment,
• Biochemical recurrence (defined as a PSA value ≥ 0.2ng/ml),
• An elevated PSA with a doubling time of \> 3 months,
• Or an estimated risk of biochemical recurrence within 5 years of 30% or more as assessed by decipher™ report (decipher score of ≥0.3).
• At the time of treatment, the subjects must have completed radical prostatectomy (rp), all additional s.o.c therapies and be clinically tumor free as defined by s.o.c imaging studies
• Written informed consent obtained prior to any study procedure.
• The subject must be able to provide the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor
• This requirement may be satisfied by providing an archival tissue sample that has been stored in rna later, flash-frozen, or under other rna/dna preserving conditions from an earlier resection.
• This requirement may also be satisfied by providing rna/dna sequencing from a CLIA certified genomic sequencing laboratory.
• Before administration of the investigational product, the following time must have elapsed:
• At least (4) weeks post general anesthesia
• At least seventy-two (72) hours post local/epidural anesthesia

You may not qualify if:

• Potential subjects who meet any of the following criteria will not be included in the study:
• The subject has metastatic disease at the time of treatment.
• Patients with history of AML or tumors with known Flt3 mutations/amplifications.
• The subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following:
• Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma.
• Subjects with tumors of the prostate with a combined Gleason Score ≤ 7
• Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case-by-case basis with eligibility determined based on discussion with the Principal Investigator.
• The subject has a prior history of unrelated neoplastic disease and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.
• The subject has a history of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), chronic active hepatitis B or hepatitis C with positive PCR.
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions.
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of:
• Vitiligo
• Hypothyroidism
• The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product.
• The subject has a history of serious allergic reaction to any substance, resulting in hospitalization or requiring other emergent medical attention.

Sponsors & Collaborators

• Ashutosh Kumar Tewari: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ashutosh Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Sujit S Nair, Ph.D.

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Dara Lundon, MD MSc MBA PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and System Chair, Milton and Carroll Petrie Department of UrologyDirector of Center of Excellence for Prostate Cancer at the Tisch Cancer Institute

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: August 18, 2021
• Study Start: January 5, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)