Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results - Nature Medicine

ALT and AST ≤3× ULN unless liver metastases are present in which case patients are included if ALT and AST ≤5 × ULNInternational normalized ratio and PT and PTT ≤1.5× ULN, unless patient is receiving anti-coagulant therapy, in which case patients are eligible if PT and PTT is within therapeutic range of intended use of anti-coagulants.

Patients with NSCLC and GEA who have been, or are currently being, treated with anti-PD-1 monotherapy are eligible.Immunosuppression that is expected to be present at the time of study treatment after vaccine production and coming from:Concurrent, recent or anticipated treatment with systemic corticosteroids or other immunosuppressive medications such as OKT3, ATG/ALG, methotrexate, tacrolimus, cyclosporine, azathioprine or rapamycin.

conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapyPatients who have had history of life-threatening TRAEs with prior immunotherapy or who have not recovered from prior cancer therapy-induced AEs .Active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism if requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted. Replacement therapy is not considered a form of systemic treatment.Any severe concurrent non-cancer disease that, in the judgment of the investigator, would make the patient inappropriate for the current study or has stabilized).

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