A Study for the Production of a Personalized Neoantigen Cancer Vaccine

The process of generating a personalized neoantigen cancer vaccine involves multiple steps,
including collection of patient tumor and blood specimens, performing next-generation
sequencing (NGS), predicting the neoantigens to be included in the patient-specific vaccine,
and the manufacture and release of the patient-specific vaccine. Gaining experience in
managing the manufacturing process will provide important insights and experience regarding
this process to be used in operationalizing future clinical trials.

Study participants will not receive any investigational treatment as part of this trial.
Patients for whom vaccine is successfully manufactured may be able to enroll in a separate
investigational treatment study sponsored by Gritstone Oncology, provided that the patient
meets the specified eligibility criteria for that treatment study.

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:

1. NSCLC who have received ≤ 1 cycle of systemic treatment with cytotoxic,
platinum-based chemotherapy (Note: patients with NSCLC who are receiving
pembrolizumab monotherapy as first line systemic monotherapy are eligible)

2. GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic,
platinum-based chemotherapy

3. mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic,
platinum-based chemotherapy

4. CRC-microsatellite stable (MSS) who have received ≤ 1 cycle of second line
systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
(Note: patients receiving first-line systemic therapy are eligible)

- 18 years of age or older

- ECOG Performance Status 0 or 1

- Available FFPE tumor specimen for sequencing and neoantigen selection

- 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:

1. For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1,
RET, or TRK

2. For CRC or GEA, patients with MSI disease

3. For CRC, patients with a known BRAF mutation or patients with peritoneal
carcinomatosis

Complete inclusion and exclusion criteria are listed in the clinical study protocol.