An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Phase 1

Active, not recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: ONO-7913; Drug: ONO-4538; Drug: Oxaliplatin; Drug: Levofolinate; Drug: Irinotecan; Drug: Fluorouracil

• Registration Number: NCT06532344
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 1. Untreated metastatic pancreatic cancer
• 2. Life expectancy of at least 3 months
• 3. Patients with ECOG performance status 0 or 1

Exclusion Criteria

• 1. Patients with severe complication
• 2. Patients with multiple primary cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-7913+ONO-4538+mFFX	ONO-7913	-
ONO-7913+ONO-4538+mFFX	ONO-4538	-
ONO-7913+ONO-4538+mFFX	Levofolinate	-
ONO-7913+ONO-4538+mFFX	Oxaliplatin	-
ONO-7913+ONO-4538+mFFX	Irinotecan	-
ONO-7913+ONO-4538+mFFX	Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities（DLT）	28 days
Adverse event(AE)	UP to 30 days after the last dose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics（serum concentration of ONO-4538）	Through study completion, an average of 6 months
Pharmacokinetics（serum concentration of ONO-7913）	Through study completion, an average of 6 months
Overall response rate (ORR)	Through study completion, an average of 6 months
Disease control rate (DCR)	Through study completion, an average of 6 months
Best overall response (BOR)	Through study completion, an average of 6 months
Duration of response (DOR)	Through study completion, an average of 6 months
Time to response (TTR)	Through study completion, an average of 6 months
Overall survival (OS)	Through study completion, an average of 6 months
Progression-free survival (PFS)	Through study completion, an average of 6 months
Percentage of change in the sum of tumor diameters of target lesions	Through study completion, an average of 6 months
Maximum percentage of change in the sum of tumor diameters of target lesions	Through study completion, an average of 6 months
Changes in tumor markers (CEA and CA19-9)	Through study completion, an average of 6 months

Trial Locations

Locations (9)

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama-shi, Kanagawa, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi, Chiba, Japan

Seirei Hamamatsu General Hospital; 🇯🇵 Hamamatsu-shi, Shizuoka, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Juntendo University Hospital; 🇯🇵 Bunkyō-Ku, Tokyo, Japan

The University of Tokyo Hospital; 🇯🇵 Bunkyō-Ku, Tokyo, Japan

The Cancer Institute Hospital ofJFCR; 🇯🇵 Koto-ku, Tokyo, Japan

Kyorin University Hospital; 🇯🇵 Mitaka-shi, Tokyo, Japan