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
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT06532331
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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
- Patients are unable to swallow oral medications
- Patients with severe complication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-7475+GnP ONO-7475 - ONO-7475+GnP Nab-paclitaxel - ONO-7475＋ONO-4538＋GnP ONO-4538 - ONO-7475＋ONO-4538＋GnP Nab-paclitaxel - ONO-7475＋ONO-4538＋GnP ONO-7475 - ONO-7475+GnP Gemcitabine - ONO-7475＋ONO-4538＋GnP Gemcitabine -
- Primary Outcome Measures
Name Time Method Dose-limiting toxicities (DLT) 28 days Adverse event (AE) Up to 28 days after the last dose
- Secondary Outcome Measures
Name Time Method CA19-9 Through study completion, an average of 6 months 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 Pharmacokinetics (Plasma concentration of ONO-7475) Up to Cycle16 Duration of Response (DOR) Through study completion, an average of 6 months Time to Response (TTR) Through study completion, an average of 6 months Best Overall Response (BOR) Through study completion, an average of 6 months Objective Response Rate (ORR) Through study completion, an average of 6 months Overall Survival (OS) Through study completion, an average of 1 year Disease Control Rate (DCR) Through study completion, an average of 6 months Progression-Free Survival (PFS) Through study completion, an average of 6 months Percent change in the sum diameters of the target lesions Through study completion, an average of 6 months CEA Through study completion, an average of 6 months Maximum percent change in the sum diameters of the target lesions Through study completion, an average of 6 months
Trial Locations
- Locations (9)
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu-shi, 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