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Clinical Trials List

Protocol Number3082-CL-0301

NCT Number(ClinicalTrials.gov Identfier)NCT07409272

Not yet recruiting

2026-07-26 - 2029-10-29

Phase III

Not yet recruiting1

Recruiting4

A phase III, double-blind, placebo-controlled, randomized trial was conducted to evaluate the efficacy and safety of ASP3082 combined with mFOLFIRINOX or NALIRIFOX as first-line treatment in participants with KRAS G12D-mutant metastatic pancreatic adenocarcinoma.

Trial Applicant

Astellas Pharma Inc.
Sponsor

Astellas Pharma Taiwan, Inc.
Trial scale

Multi-Regional Multi-Center
Update

2026/09/15

Investigators and Locations

Principal Investigator Li-Yuan Bai 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator SHIH-HUNG YANG 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yao-Yu Hsieh 無

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Pin Li 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chi Chou

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic pancreatic adenocarcinoma

Objectives

*Primary Objective: To compare overall survival (OS) between participants receiving ASP3082 plus mFOLFIRINOX or NALIRIFOX versus placebo plus mFOLFIRINOX or NALIRIFOX. *Key secondary objectives: Compare disease progression-free survival (PFS) between participants receiving ASP3082 plus mFOLFIRINOX or NALIRIFOX, versus placebo plus mFOLFIRINOX or NALIRIFOX; Compare time to improvement in pancreatic pain (TIPP); Compare time to deterioration in overall health status (GHS)/quality of life (QoL) (TWGQ); Compare objective response rate (ORR) between participants receiving ASP3082 plus mFOLFIRINOX or NALIRIFOX, versus placebo plus mFOLFIRINOX or NALIRIFOX; Compare safety and tolerability between participants receiving ASP3082 plus mFOLFIRINOX or NALIRIFOX, versus placebo plus mFOLFIRINOX or NALIRIFOX; Evaluate the pharmacokinetics (PK) of ASP3082 (and applicable metabolites); In EORTC QLQ-PAN26, EORTC The impact on QoL, function, and symptoms was assessed using the QLQ-C30, the European Quality of Life Questionnaire 5-Dimensional 5-Level Version (EQ-5D-5L), Patient Overall Impression of Change (PGIC), and Patient Overall Severity Impression (PGIS).

Test Drug

"Xinghui" Xingrui Platinum Intravenous Injection 5 mg/mL
ASP3082
Haofu Injection 50 mg
Anengde Liposome Injection
Kefeiyan Injection 10 mg
Anticancer Intravenous Concentrate
Erenodin Concentrate Injection
Fulinya Injection 10 mg/mL
Yilinuo Intravenous Infusion Solution
Yile Platinum Injection 5 mg/mL

Active Ingredient

OXALIPLATIN
ASP3082
FLUOROURACIL
IRINOTECAN HYDROCHLORIDE
FOLINATE CALCIUM (CALCIUM LEUCOVORIN)
IRINOTECAN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE
LEUCOVORIN CALCIUM (ANHYDRIDE)
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
OXALIPLATIN

Dosage Form

Injection solution
Infusion solution
Injection solution
Injection solution
Injection solution
Injection solution
Injection solution
Injection solution
Injection solution
Injection solution

Dosage

5 mg/ml
600 mg/6 mL
50 mg/ml
4.3 mg/ml
10.85 mg/ml
20 mg/ml
20 mg/ml
10 mg/ml
20 mg/ml
5 mg/ml

Endpoints

Overall survival (OS) is defined as the time elapsed from a randomly assigned date to a date of death from any cause.

Inclution Criteria

Age

1. Your age is ≥ 18 years at the time of signing the participant consent form.

Participant Type and Disease Characteristics

2. You have histologically confirmed metastatic PDAC and are confirmed to have a KRAS G12D mutation by local or central testing (a positive KRAS G12D mutation status is required before randomization).

3. Surgical resection or eradicative radiation therapy is not a treatment option for you.

Gender and Contraception Requirements

(For further details, please contact the contact person for this case or the research team at the respective participating hospital.)

Exclusion Criteria

Medical Conditions

1. You have symptomatic or untreated CNS metastases (participants with asymptomatic CNS metastases or those receiving treatment are eligible).

2. You have a pre-existing malignancy with signs of leptomeningeal disease.

3. You have neuroendocrine, acinar pancreatic carcinoma, or pancreatic carcinoma with squamous/adenosquamous features.

4. Within the past 2 years, you have had an active malignancy different from the malignancy being studied in this trial (i.e., requiring treatment, including hormone therapy or interventional therapy); however, locally resected malignancies are excluded, such as basal or squamous cell skin cancer, superficial bladder cancer, or cervical or breast carcinoma in situ, in which case a history of the aforementioned cancers is permitted.

5. You have active hepatitis B (including acute or chronic HBV) or HCV (qualified RNA detection by qualitative assay). HCV RNA testing is not required for participants with negative HCV antibody tests.

(For further details, please contact the contact person for this case or the research team at the respective trial hospital.)

The Estimated Number of Participants

Taiwan

15 participants
Global

614 participants