A Study of a Personalized Neoantigen Cancer Vaccine

Study summary

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGRT-C901 and GRT-R902

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 13, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?Gritstone bio, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Gritstone bio, Inc.
Interventions being studied: Biological: GRT-C901; Biological: GRT-R902; Biological: nivolumab; Biological: ipilimumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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: 1. NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible) 2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 4. CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
18 years of age or older
ECOG Performance Status 0 or 1
Lesion amenable to biopsy
Measurable disease according to RECIST v1.1
Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

Reasons someone may not be able to joinExclusion criteria

Tumors with genetic characteristics as follows: 1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK 2. For CRC and GEA, patients with known MSI-high disease based on institutional standard 3. For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws Complete inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic ArizonaPhoenix, Arizona
Mayo ClinicJacksonville, Florida
The University of ChicagoChicago, Illinois
Mayo ClinicRochester, Minnesota
Memorial Sloan Kettering Cancer CenterNew York, New York
Columbia University Medical CenterNew York, New York
The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Tennessee OncologyNashville, Tennessee
MD Anderson Cancer CenterHouston, Texas
Virginia Cancer SpecialistsFairfax, Virginia
Peter MacCallum Cancer CentreMelbourne, Victoria

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 13, 2023. Always confirm current availability with the study team.

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