A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
A PhaseⅠStudy to Examine Tolerability and Safety of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and Safety of ONO-7475 in Combination With GnP in Patients With Metastatic Pancreatic Cancer as First-line Treatment
1 other identifier
interventional
87
1 country
9
Brief Summary
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2023
CompletedFirst Submitted
Initial submission to the registry
July 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 18, 2025
April 1, 2025
3.8 years
July 28, 2024
April 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities (DLT)
28 days
Adverse event (AE)
Up to 28 days after the last dose
Secondary Outcomes (14)
Pharmacokinetics (Plasma concentration of ONO-7475)
Up to Cycle16
Pharmacokinetics (Plasma concentration of ONO-4538)
Through study completion, an average of 6 months
Anti-ONO-4538 antibody
Through study completion, an average of 6 months
Objective Response Rate (ORR)
Through study completion, an average of 6 months
Disease Control Rate (DCR)
Through study completion, an average of 6 months
- +9 more secondary outcomes
Study Arms (2)
ONO-7475+GnP
EXPERIMENTALONO-7475＋ONO-4538＋GnP
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient with metastatic pancreatic cancer
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 6 months
You may not qualify if:
- Patients are unable to swallow oral medications
- Patients with severe complication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hpspital
Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2024
First Posted
August 1, 2024
Study Start
December 6, 2023
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
April 18, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share