Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT03953235
Eligibility Criteria:
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. 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.
2. 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.
3. 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.
4. 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:
1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
2. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03953235
Study Brief:
Protocol Section:
NCT03953235