FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers

Inclusion criteria

• . For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with applicable FDA-approved targeted therapies, including multi-kinase inhibitors. Patients whose tumors have deficient mismatch repair (dMMR)/high microsatellite instability (MSI-H) must have received an immune checkpoint inhibitor prior to enrolling in this study.
• . For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients with the appropriate PD-L1 expression score must have received treatment with an FDA-approved checkpoint inhibitor with or without chemotherapy consistent with the FDA-approved label.
• . Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients whose tumors have dMMR/MSI-H must have received an immune checkpoint inhibitor prior to enrolling in this study.
• . ANC ≥1000/mm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)
• . Platelets ≥75,000/mm3 without transfusion within the preceding 7 days of screening.
• . Hemoglobin ≥8.0 g/dL (≥80 g/L); blood transfusion permitted within 7 days of screening.
• . AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.