Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 9, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
Metastatic Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma
Interventions
DRUG

5-Fluorouracil

Participants will be administered 2400 mg/m\^2 of 5-Fluorouracil via continuous intravenous infusion over a 46-hour period beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.

DRUG

Oxaliplatin

Participants will be administered 85 mg/m\^2 of Oxaliplatin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.

DRUG

Leucovorin

Participants will be administered 400 mg/m\^2 of Leucovorin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.

DRUG

Irinotecan

Participants will be administered 150 mg/m\^2 of Irinotecan via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.

DRUG

Gemcitabine

Participants will be administered 1000 mg/m\^2 of Gemcitabine standard of care (SOC) via intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.

DRUG

Nab Paclitaxel

Participants will be administered 125 mg/m\^2 of Nab Paclitaxel standard of care (SOC) by intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.

DIAGNOSTIC_TEST

Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay

"ctDNA will be measured in participants in person via blood samples during Screening/Baseline and at the following intervals during treatment and follow-up:~* Every weeks 2 beginning at weeks 2, 4, 6 and 8 of standard of care therapy.~* Every 4 weeks beginning at week 10 of standard of care therapy until disease progression.~ctDNA will be measured to obtain participant tumor methylation scores (TMS)."

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

BillionToOne, Inc

UNKNOWN

lead

University of Miami

OTHER

NCT07096362 - Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma | Biotech Hunter | Biotech Hunter