Clinical trial NCT06532331: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Dose-limiting toxicities (DLT)
timeFrame: 28 days
measure: Adverse event (AE)
timeFrame: Up to 28 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics (Plasma concentration of ONO-7475)
timeFrame: Up to Cycle16
measure: Pharmacokinetics (Plasma concentration of ONO-4538)
timeFrame: Through study completion, an average of 6 months
measure: Anti-ONO-4538 antibody
timeFrame: Through study completion, an average of 6 months
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, an average of 6 months
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 6 months
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 1 year
measure: Progression-Free Survival (PFS)
timeFrame: Through study completion, an average of 6 months
measure: Duration of Response (DOR)
timeFrame: Through study completion, an average of 6 months
measure: Time to Response (TTR)
timeFrame: Through study completion, an average of 6 months
measure: Best Overall Response (BOR)
timeFrame: Through study completion, an average of 6 months
measure: Percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 6 months
measure: Maximum percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 6 months
measure: CEA
timeFrame: Through study completion, an average of 6 months
measure: CA19-9
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hpspital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: