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Clinical Trials in Japan / NCT06532331
Active, not recruiting Phase 1

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

NCT06532331 · tracked via the Priya Life Science Japan tracker
Sponsor
Ono Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2023-12-06
Last updated
2025-04-18

Condition(s) studied

Metastatic Pancreatic Cancer

Investigational drug(s) / intervention(s)

ONO-7475ONO-4538 →Nab-paclitaxel →Gemcitabine →

ONO-7475: Specified dose on specified days

ONO-4538: Specified dose on specified days

Nab-paclitaxel: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient with metastatic pancreatic cancer 2. Patients have an ECOG performance status of 0 to 1 3. Patients with a life expectancy of at least 6 months Exclusion Criteria: 1. Patients are unable to swallow oral medications 2. Patients with severe complication

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Aichi Cancer Center Nagoya Aichi-ken
National Cancer Center Hospital East Kashiwa-shi Chiba
Kanazawa University Hospital Kanazawa Ishikawa-ken
Kanagawa Cancer Center Yokohama Kanagawa
Osaka International Cancer Institute Osaka Osaka
Seirei Hamamatsu General Hospital Hamamatsu Shizuoka
Juntendo University Hpspital Bunkyo-ku Tokyo
The University of Tokyo Hospital Bunkyo-ku Tokyo
The Cancer Institute Hospital Of JFCR Koto-Ku Tokyo

More Ono Pharmaceutical Co., Ltd. trials in Japan

A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia Recruiting
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus Recruiting
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors Active, not recruiting
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting
ONO-4538 Study in Patients With Richter's Transformation Recruiting

Other trials for the same condition

A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer Active, not recruiting
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer Recruiting
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 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06532331 on ClinicalTrials.gov ↗ ← All trials in Japan