XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Progression Free Survival (PFS)

Progression free survival (PFS) was defined as the time from randomization to first progression based on RECIST v1.1 criteria or death from any cause, whichever occurred first. Subjects who had no baseline and post-baseline tumor assessment and no death, or no adequate post-baseline tumor assessment and no death were censored at the date of randomization. Subjects alive and without documented disease progression at the time of data analysis are censored at the date of the last adequate tumor assessment.

Time frame: From baseline until the date of first documented disease progression or date of death (from any cause), whichever come first.

Overall Survival (OS)

OS was defined as the duration from the date of randomization until death irrespective of the cause. Subjects who were alive at the time of analysis were censored at the last known date alive. Subjects without any data after baseline were censored on the randomization day.

Time frame: From baseline until death from any cause

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the proportion of subjects in the Phase II Population who achieved a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR), as defined by RECIST v1.1 criteria.

Time frame: Analyses performed at Visit 5 (Week 8), Visit 9 (Week 16), and Visit 13 (Week 24). This outcome measure was reported for Visit 13.

Time to Treatment Failure(TTF)

TTF measures the time from randomization to discontinuation of treatment for any reason, including, but not limited to, disease progression, treatment-related toxicity, and/or death during study.

Time frame: From baseline until treatment failure assessed up to Visit 13 (Week 24)

Number of Serious Adverse Events (SAEs)

This outcome measure calculates the total number of unique participants who reported serious adverse events (SAEs) in each group. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.

Incidence of Grade 3-4 Diarrhea

This measure tracks the overall burden of severe (Grade 3) or life-threatening (Grade 4) diarrhea as defined by the NCI CTCAE v5.0. Grade 3 events are severe enough to require medical intervention or significantly limit a person's ability to care for themselves, while Grade 4 events represent urgent, life-threatening clinical situations.

Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.

Duration of Hospitalization

This outcome measure calculates the sum of duration of hospitalizations during the study period in phase II population for both groups.

Time frame: From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion.

Plasma Concentration of Natrunix

Measurement of the concentration of Natrunix in plasma samples to evaluate the pharmacokinetic profile. Due to reporting limitations on this portal, results from only one time point are reported here. For Phase 1, samples were collected at V1 pre-dose, V1 post-dose, V2 pre-dose, V3 follow up. For phase 2, samples were collected at V1 pre-dose, V1 post-dose, V1 Day 4, V1 Day 7, V2 pre-dose, V3 pre-dose, V4 pre-dose, V6 pre-dose, V8 pre-dose, and V13 follow up. Placebo patients were tested at V1 post-dose only for verification.

Time frame: Reported results Natrunix: Phase I: V1 post-dose collected at 30 min post-infusion at visit 1(Week 0), which represents Cmax of Cycle 1. Phase II: V6 pre-dose, at Visit 6 (Week 10), represents the trough of steady state concentration.

Number of Treatment Cycles

This measures the total number of cycles (total number of doses) received by subjects after randomization in each arm.

Time frame: From randomization to end of study or study discontinuation for any reasons, up to 24 weeks