Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Eligibility Criteria

• 1. Participant must be 18 years of age or older at the time of signing the informed consent.
• 2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC).
• 3. 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).
• 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
• 5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
• 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.
• 7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\]).
• 8. 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.
• 9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
• 10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
• 11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.
• 1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
• 2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are up to 1.5cm in diameter that have been treated, if clinically indicated.
• 3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
• 4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
• 5. Participant has any form of primary or acquired immunodeficiency.
• 6. Participant has a history of hypersensitivity to any component of the study intervention.
• 7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
• 8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
• 9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
• 10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
• 11. Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.