Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OBX-115 · 1 trial · 7 indications
• 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 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)
| Arm | Type | Description |
|---|---|---|
| Participants with advanced solid tumors | EXPERIMENTAL | Participants will receive conditioning therapy prior to administration of OBX-115 regimen. |
| Name | Type | Description |
|---|---|---|
| OBX-115 | BIOLOGICAL | A 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. |
Inclusion 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 or relapsed refractory metastatic non-small cell lung cancer (NSCLC). 3. Cohort and indication spe...
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