Advanced Cancer
Conditions
Keywords
Vaccine, neoantigen
Brief summary
Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer
Detailed description
This is an open-label Phase 1 study to determine the safety and tolerability of single-agent treatment with AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer that is refractory to standard therapies and a life expectancy of ≥6 months from the time tissue is obtained. A minimum of 6 (≤20) subjects will be enrolled to receive every other week subcutaneous injection of 240 μg AutoSynVax™ vaccine + 50 μg QS-21 Stimulon® adjuvant for up to 1 year.
Interventions
BIOLOGICALAutoSynVax™ vaccine
AutoSynVax™ vaccine + QS-21 Stimulon® adjuvant
Sponsors
Agenus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Prior to vaccine production - 1. Diagnosis of advanced cancer (solid tumor) that: 1. May be receiving or about to start another line of therapy. 2. 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. 2. 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. 3. Minimum estimated life expectancy of 6 months. 4. Age 18 years or older. 5. Signed written informed consent to allow transfer of tumor tissue and production of vaccine. 6. 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.: 1. Diagnosis of advanced cancer (solid tumor) that is refractory to standard therapies. 2. Signed written informed consent for treatment. 3. Minimum estimated life expectancy of 3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<2. 5. Adequate bone marrow function (absolute neutrophil count \[ANC\] ≥1,500/mm\^3; absolute lymphocyte count \[ALC\] ≥500/mm\^3; platelet count 100,000/mm\^3), adequate liver function (serum glutamic oxaloacetic transaminase \[SGOT\]/aspartate aminotransferase \[AST\] and alkaline phosphatase \<2.5 times the institutional upper limit of normal \[IULN\], total bilirubin \<1.5 mg/dL), and adequate renal function (creatinine \<1.5 x IULN). 6. Adequate cardiac function (New York Heart Association \[NYHA\] class ≤II). 7. All participants (males and females) must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study treatment and for the duration of study participation. Female subjects of childbearing potential should have a negative serum pregnancy test at pre-treatment visit and within 72 hours prior to receiving the first dose of study medication. Female subjects of childbearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity prior to receiving the first dose of study medication through 30 days after the last dose of study medication.
Exclusion criteria
Subjects must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability) | From first administration to 30 days from last dose. | AEs, irAEs, according to NCI CTCAE version 4.03. |
| Recommended dose for further development | 28 days from first dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From first administration until death, or up to study duration (18 - 24 months) | Duration of survival |
| Progression-free survival (PFS) | 6 Months after last dose is administered. | From time of first administration per RECIST v1.1 |
| Objective response rate (ORR) | 6 Months after last dose is administered. | From time of first administration per RECIST v1.1 |
| T-cell response | 6 Months after last administration. | T-cell response to tumor specific neo-epitopes in the vaccine |
Countries
United States
Outcome results
None listed