- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03953235
A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Andy Ferguson
- Phone Number: 857-327-9816
- Email: aferguson@gritstone.com
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Mayo Clinic Arizona
-
-
California
-
Santa Monica, California, United States, 90404
- UCLA Medical Center
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medicine, Comprehensive Cancer Center
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10032
- Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Comprehensive Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
Patients with the indicated advanced or metastatic solid tumor as follows:
- Microsatellite-stable colorectal cancer (MSS-CRC) who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin and/or irinotecan that may include a VEGF or EGFR targeting therapy as their 1L therapy for metastatic disease OR who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan that may include a VEGF or EGFR targeting therapy and have not received additional lines of systemic therapy in the metastatic setting.
- Non-small cell lung cancer (NSCLC) who are currently receiving systemic treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy OR who have experienced disease progression following treatment with an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy (or anti-PD-(L)1 alone if patient refuses platinum-based chemotherapy), and have not received additional lines of systemic therapy in the metastatic setting.
- Pancreatic ductal adenocarcinoma (PDA) who are currently receiving systemic cytotoxic chemotherapy as their 1L therapy for metastatic disease OR who have experienced disease progression on 1L systemic cytotoxic chemotherapy and have received no more than 1 prior line of therapy in the metastatic setting.
- Any solid tumor histology where the patient has experienced disease progression with all available therapies known to confer clinical benefit
- Patient's tumor possesses one of the mutations listed below, and is determined to express a HLA allele for antigen presentation of the identified tumor mutation:
VERSION 1.0 of the expression cassette:
BRAF_G466V // CTNNB1_S37F // CTNNB1_S45F // CTNNB1_S45P // CTNNB1_T41A // ERBB2_Y772_A775dup // KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V // KRAS_G13D // KRAS_Q61H or NRAS_Q61H // KRAS_Q61K or NRAS_Q61K // KRAS_Q61L or NRAS_Q61L // KRAS_Q61R or NRAS_Q61R // TP53_K132E // TP53_K132N // TP53_R213L // TP53_R249M // TP53_S127Y
VERSION 2.0 of the expression cassette:
KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V or NRAS_G12V // KRAS_Q61H or NRAS_Q61H
- ECOG Performance Status 0 or 1
- Measurable disease according to RECIST v1.1
- Adequate organ function, as measured by laboratory values (criteria listed in protocol)
Exclusion Criteria:
Tumors with genetic characteristics as follows:
- For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
- Patients with known MSI-high disease based on institutional standard
- Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination
- Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws
- History of allogenic/solid organ transplant
- Active, known, or suspected autoimmune disease
- Active tuberculosis or recent (<2 week) clinically significant infection, or evidence of active hepatitis B or hepatitis C
- Known history of positive test for human immunodeficiency (HIV) or known acquired immunodeficiency syndrome (AIDS)
Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1
|
anti-PD-1 monoclonal antibody
anti-CTLA-4 monoclonal antibody
a shared neoantigen cancer vaccine prime
a shared neoantigen cancer vaccine boost
|
Experimental: Phase 2
Phase 2 for some patients includes a monthly or every two month treatment schedule |
anti-PD-1 monoclonal antibody
anti-CTLA-4 monoclonal antibody
a shared neoantigen cancer vaccine prime
a shared neoantigen cancer vaccine boost
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months)
|
Initiation of study treatment until disease progression (up to approximately 27 months)
|
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)
Time Frame: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
|
Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
|
Identify the recommended Phase 2 dose (RP2D) of GRT-C903 and GRT-R904
Time Frame: Up to approximately 6 months
|
Up to approximately 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: Up to approximately 4 years
|
Up to approximately 4 years
|
Progression-free survival (PFS)
Time Frame: Up to approximately 4 years
|
Up to approximately 4 years
|
Measure the immune response to the neoantigens encoded by GRT-C903 and GRT-R904
Time Frame: Baseline to end of treatment (up to approximately 12 months)
|
Baseline to end of treatment (up to approximately 12 months)
|
Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months)
|
Initiation of study treatment until disease progression (up to approximately 27 months)
|
Duration of response (DOR) using RECIST v1.1
Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months)
|
Initiation of study treatment until disease progression (up to approximately 27 months)
|
Clinical benefit rate (CBR) using RECIST v1.1
Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months)
|
Initiation of study treatment until disease progression (up to approximately 27 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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