Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

Progression-free Survival (PFS) - Overall Population

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first.

Time frame: Through study completion, an average of 1 year

Objective Response Rate (ORR) - Biomarker Enriched Population

Objective response rate (ORR) is defined as the proportion of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) as assessed by the investigators per RECIST v1.1. The BOR is the best response (in the order of CR, PR, stable disease \[SD\], and progressive disease \[PD\]) documented from the date of randomization until the end of study, first disease progression, death, or start of new anti-cancer therapy, or last documented assessment before ≥2 consecutive missing tumor assessments, whichever is earlier.

Time frame: Through study completion, an average of 1 year

Overall Survival (OS) - Biomarker Enriched Population

OS is defined as the time from randomization until death due to any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Outcome measure is the Kaplan-Meier estimate of OS rate at 12 months.

Time frame: Through study completion

Number of Participants With Treatment Emergent Adverse Events

Number of treatment emergent adverse events in all participants who received any dose of study treatment.