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A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523684-38-00
Enrollment
69
Registered
2026-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult participants with metastatic PDAC with KRAS G12D mutation

Brief summary

Overall Survival (OS), defined as the time from the date of randomization until the date of death from any cause

Detailed description

Progression-free survival (PFS) per RECIST v1.1, as assessed by the investigator, TIPP, EORTC QLQ-PAN26, TWGQ, EORTC QLQ-C30, Objective response rate (ORR) per RECIST v1.1, as assessed by the investigator, Safety and tolerability evaluated via the following: AEs, SAEs, laboratory test results, ECGs, vital signs and ECOG Performance Status, End of infusion concentration and Ctrough, Change from baseline in EORTC QLQ-PAN26, EORTC QLQ-C30, EQ-5D-5L, PGIC and PGIS

Interventions

DRUGDextrose 5% in water solution for infusion
DRUGASP3082

Sponsors

Astellas Pharma Global Development Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS), defined as the time from the date of randomization until the date of death from any cause—

Secondary

MeasureTime frame
Progression-free survival (PFS) per RECIST v1.1, as assessed by the investigator, TIPP, EORTC QLQ-PAN26, TWGQ, EORTC QLQ-C30, Objective response rate (ORR) per RECIST v1.1, as assessed by the investigator, Safety and tolerability evaluated via the following: AEs, SAEs, laboratory test results, ECGs, vital signs and ECOG Performance Status, End of infusion concentration and Ctrough, Change from baseline in EORTC QLQ-PAN26, EORTC QLQ-C30, EQ-5D-5L, PGIC and PGIS—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 12, 2026