Clinical trial NCT06538207: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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 for ONO-4578)
timeFrame: Up to 28 days after the last dose
measure: Pharmacokinetics (Serum concentration for ONO-4538)
timeFrame: Up to 28 days after the last dose
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Duration of response (DOR)
timeFrame: Up to 2 years
measure: Time to response (TTR)
timeFrame: Up to 2 years
measure: Best overall response (BOR)
timeFrame: Up to 2 years
measure: Percentage of change in the sum of tumor diameters of target lesions
timeFrame: Up to 2 years
measure: Maximum percentage of change in the sum of tumor diameters of target lesions
timeFrame: Up to 2 years
measure: Changes in tumor markers (CEA and CA19-9)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Hamamatsu-shi
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: