Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Inclusion Criteria11

• Participant must be 18 years of age or older at the time of signing the informed consent.
• Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC).
• Melanoma participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease). Participant must not have been exposed to both taxane and gemcitabine.
• Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
• After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.
• Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\]).
• Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.
• Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
• Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
• Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.