A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens

Overview

About this study

The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

For Phase 1

  • 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 or 2L 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, but have not initiated a new line of therapy;
  • 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 an anti-PD-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy (or antiPD-(L)1 alone if patient refuses platinum-based chemotherapy), but have not initiated a new line of therapy;
  • 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, but have not initiated a new line of therapy;
  • Any solid tumor histology where the patient has experienced disease progression with all available therapies known to confer clinical benefit.

For Phase 2

  • 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;
  • 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 an anti-PD-(L)1 antibody followed by 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 (Patients whose tumor harbors KRAS G12C may also receive a targeted therapy that inhibits KRAS G12C as prior therapy in addition to pembrolizumab and platinum-based chemotherapy);
  • 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 as determined per local institutional standard.
  • ≥ 18 years of age.

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 within the prior 5 months or any history of anaphylaxis in reaction to a vaccination or hypersensitivity to study drug components.
  • Bleeding disorder (e.g., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws.
  • Patient has received prior therapy consisting of anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with the exception of patients with NSCLC or a mutation-positive solid tumor.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amit Mahipal, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Daniel Ahn, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeremy Jones, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20478019

Mayo Clinic Footer