An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Phase 1

Active, not recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: ONO-4578; Drug: ONO-4538; Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Levofolinate; Drug: Nab-Paclitaxel; Drug: Irinotecan; Drug: Fluorouracil

• Registration Number: NCT06538207
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Primary Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 1. Pancreatic invasive ducatal adenocarcinoma
• 2. Life expectancy of at least 3 months
• 3. Patients with ECOG performance status 0 or 1

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4578+ONO-4538+mFFX	Levofolinate	-
ONO-4578+ONO-4538+mFFX	ONO-4578	-
ONO-4578+ONO-4538+mFFX	ONO-4538	-
ONO-4578+ONO-4538+GnP	ONO-4578	-
ONO-4578+ONO-4538+GnP	ONO-4538	-
ONO-4578+ONO-4538+GnP	Nab-Paclitaxel	-
ONO-4578+ONO-4538+mFFX	Oxaliplatin	-
ONO-4578+ONO-4538+GnP	Gemcitabine	-
ONO-4578+ONO-4538+mFFX	Irinotecan	-
ONO-4578+ONO-4538+mFFX	Fluorouracil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	Up to 2 years
Overall response rate (ORR)	Up to 2 years
Pharmacokinetics (Serum concentration for ONO-4538)	Up to 28 days after the last dose
Disease control rate (DCR)	Up to 2 years
Progression-free survival (PFS)	Up to 2 years
Time to response (TTR)	Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Pharmacokinetics (Plasma concentration for ONO-4578)	Up to 28 days after the last dose
Overall survival (OS)	Up to 2 years
Best overall response (BOR)	Up to 2 years
Changes in tumor markers (CEA and CA19-9)	Up to 2 years

Trial Locations

Locations (9)

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

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

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

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

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

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Koto-Ku, Tokyo, Japan

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

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