Brief Title: A Study of a Personalized Neoantigen Cancer Vaccine

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)

Primary Outcome 2 - Measure: Objective Response Rate (ORR) in Phase 2 using RECIST v1.1

Primary Outcome 2 - Timeframe: Initiation of study treatment until disease progression (up to approximately 27 months)

Primary Outcome 3 - Measure: Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902

Primary Outcome 3 - Timeframe: Up to approximately 6 months

CONDITION

• Non Small Cell Lung Cancer
• Colorectal Cancer
• Gastroesophageal Adenocarcinoma
• Urothelial Carcinoma

ELIGIBILITY

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:
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)

- GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy

- mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy

- 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)
Exclusion Criteria:
Tumors with genetic characteristics as follows:
For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK

- For CRC and GEA, patients with known MSI-high disease based on institutional standard

- 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 exclusion criteria are listed in the clinical study protocol.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 857-327-9816

Email: aferguson@gritstone.com

LOCATION