Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer

NCT02992977 | Terminated Phase 1

• 1 other identifier: C-600-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer

Conditions

Advanced Cancer

Keywords

Vaccine, neoantigen

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)

  AEs, irAEs, according to NCI CTCAE version 4.03.

  From first administration to 30 days from last dose.

• Recommended dose for further development

  After 2 doses (administered every 2 weeks), if there are \<2 treatment-limiting toxicities (TLTs) in the first 6 subjects, AutoSynVax™ vaccine will be considered safe for further development.

  28 days from first dose

Secondary Outcomes (4)

• Overall survival (OS)

  From first administration until death, or up to study duration (18 - 24 months)

• Progression-free survival (PFS)

  6 Months after last dose is administered.

• Objective response rate (ORR)

  6 Months after last dose is administered.

• T-cell response

  6 Months after last administration.

Study Arms (1)

AutoSynVax™ vaccine

EXPERIMENTAL

AutoSynVax™ vaccine + QS-21 Stimulon® adjuvant

Biological: AutoSynVax™ vaccine

Interventions

AutoSynVax™ vaccine BIOLOGICAL

AutoSynVax™ vaccine + QS-21 Stimulon® adjuvant

AutoSynVax™ vaccine

Eligibility Criteria

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

You may qualify if:

• Prior to vaccine production -
• Diagnosis of advanced cancer (solid tumor) that:
• May be receiving or about to start another line of therapy.
• If on a line of therapy or about to start a new line of therapy, it is anticipated that the treatment may provide short-term tumor control.
• Available tissue from an archival tissue sample or tissue from a biopsy done during the initial screen, or both. If archival tissue is not available or tissue is not mainly tumor, subjects must be willing to undergo a biopsy or surgery to remove some or all of their tumor for next generation sequencing. New tissue should be obtained prior to starting a new line of therapy, if applicable.
• Minimum estimated life expectancy of 6 months.
• Age 18 years or older.
• Signed written informed consent to allow transfer of tumor tissue and production of vaccine.
• Discussion about each patient should occur with the Medical Monitor to confirm eligibility.
• Prior to Treatment -
• Patients who had vaccine manufactured but were treated with an additional line of treatment may start vaccine if they continue to meet the remaining eligibility criteria.:
• Diagnosis of advanced cancer (solid tumor) that is refractory to standard therapies.
• Signed written informed consent for treatment.
• Minimum estimated life expectancy of 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status \<2.

You may not qualify if:

• Diagnosis of immunodeficiency or actively receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Corticosteroid dependency.
• Requirement for immunosuppressive medication aside from corticosteroids.
• Active or history of any autoimmune disease (subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
• History of treated or untreated brain metastases or leptomeningeal spread of disease.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Known medical, psychiatric or substance abuse disorders that would preclude participation in the study.
• Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Known to be positive for human immunodeficiency virus (HIV). Testing is not required in the absence of history or high index of suspicion.
• Intolerance of prior immunotherapy treatment necessitating cessation of therapy.
• History of intolerance or allergic reactions attributed to compounds of similar chemical or biologic composition to AutoSynVax™ vaccine or QS-21.
• Women who are pregnant or breastfeeding.
• Inability to comply with protocol.
• Receipt of anticancer medications or investigational drugs within the following intervals before first administration of study drug:
• ≤14 days for chemotherapy, targeted small molecule therapy, anticancer hormone therapy or radiation therapy. Subjects must also not have had radiation pneumonitis as a result of treatment, and cannot participate in the study if they are on chronic corticosteroids for radiation pneumonitis or other reasons. A 1-week washout is permitted for palliative radiation to non-CNS disease with sponsor approval.

Sponsors & Collaborators

• Agenus Inc.: lead

Study Sites (2)

School of Medicine at the University of Miami

Miami, Florida, 33136, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Medical Director

  Agenus Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 14, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)