This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
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 or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
Participants with unresectable or metastatic melanoma must have 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.
Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
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 that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.
Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
Single group
OBX-115
Biological/VaccineA tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.
Incidence and nature of dose-limiting toxicities (DLTs)
• Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
• The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 3)
The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
• The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 1, 2, and 4)
The proportion of participants who have a confirmed CR or PR per RECIST v1.1
• The proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 1)
Incidence of AEs
• Incidence of treatment-emergent adverse events (TEAEs), including SAEs, study intervention related AEs, and AEs leading to early discontinuation of study intervention or withdrawal from the Assessment Period or death up to 2 years after initiation of study intervention
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