Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients

NCT03120832 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: PAN0216
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose

  Through the 21 day interval after the first dose of vaccine

Secondary Outcomes (1)

• Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Adverse Events

  Through study completion, an average of 3 months. Patients were able to continue on treatment with one patient receiving approximately 15 months of treatment.

Study Arms (1)

PAN-301-1 (SNS-301) Vaccine

EXPERIMENTAL

PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days

Biological: PAN-301-1

Interventions

PAN-301-1 BIOLOGICAL

Also known as: SNS-301

PAN-301-1 (SNS-301) Vaccine

Eligibility Criteria

• Age: 21 Years - 85 Years
• Gender Eligibility Details: Must be male subject having diagnosis of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written Ethics Committee approved informed consent
• Men aged 21 to 85 years with a histologic diagnosis of prostate cancer with a biochemical relapse following definitive local therapy (RP or radiation therapy)
• Patients are not eligible or are unwilling to receive additional definitive therapy following relapse (either RP or radiation therapy)
• No prior cytotoxic chemotherapy for the current cancer
• Normal electrocardiogram (ECG) or ECG with no clinically significant findings as determined by the Principal Investigator
• Presence of biochemically relapsed prostate cancer defined as either: 1) PSA \> 2 ng/mL 1 year following initial definitive treatment for prostate cancer: or, 2) PSA doubling time (greater than 0.2 ng/mL) \< 12 months; or, 3) PSA velocity \> 2 ng/mL/year at any time following radical prostatectomy or radiation therapy.
• Positive expression of HAAH in either archived tumor tissue (if available) or fresh serum
• No clinical or radiologic evidence of distant metastatic disease as measured by pelvic MRI or CT scan in addition to bone scan. These studies will need to be performed within 56 (+ 7 days) days prior to the start of the study.
• No history of immunosuppressive disease
• No evidence of active autoimmune disease. Active autoimmune disease is defined as any disease process that has specifically needed administration of immune suppressive and or cytoreductive therapy currently or within the last 1 year.
• Able and willing to comply with all study procedures

You may not qualify if:

• PSA doubling time of \< 3 months
• Participation in a clinical trial within 30 days prior to enrollment
• Prior major surgery or radiation therapy within 4 weeks of enrollment
• Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint
• Screening blood counts of the following:
• Hematopoietic:
• Absolute neutrophil count \< 1500/μL, Platelets \< 100,000/μL, Hemoglobin \< 9 g/dL;
• Liver/Metabolic:
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) \> 2.5 × ULN range, Total bilirubin \> 2 × ULN, Albumin \< 2.8 g/dL;
• Renal:
• Creatinine clearance \< 50 mL/min as predicted by the Cockcroft-Gault formula
• Subjects whose partners are WOCBP must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug
• Current or anticipated concomitant immunosuppressive therapy (excluding nonsystemic inhaled, topical skin and/or eye drop-containing corticosteroids)
• Any concurrent condition requiring the continued use of systemic steroids (see above) or the use of immunosuppressive agents including methotrexate. All other systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment
• Receipt of any blood product within 1 month of enrollment

Sponsors & Collaborators

• Sensei Biotherapeutics, Inc.: lead
• Accelovance: collaborator

Study Sites (4)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Dr. James J. Elist

Beverly Hills, California, 90211, United States

Location

GU Research Network/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ramzi Melhem MD Medical Director
• Organization: Senseibio

rmelhem@senseibio.com

9168336928

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: April 19, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 12, 2021
• Results First Posted: November 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)