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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06532344

Enrollment

32

Registered

2024-08-01

Start date

2021-07-30

Completion date

2026-12-31

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

Brief summary

To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Interventions

Specified dose on specified days

Specified dose on specified days

DRUGOxaliplatin

Specified dose on specified days

DRUGLevofolinate

Specified dose on specified days

DRUGIrinotecan

Specified dose on specified days

DRUGFluorouracil

Specified dose on specified days

Sponsors

Ono Pharmaceutical Co. Ltd

Lead SponsorINDUSTRY

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 1\. Untreated metastatic pancreatic cancer * 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

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities（DLT）	28 days
Adverse event(AE)	UP to 30 days after the last dose

Secondary

Measure	Time frame
Overall response rate (ORR)	Through study completion, an average of 6 months
Disease control rate (DCR)	Through study completion, an average of 6 months
Overall survival (OS)	Through study completion, an average of 6 months
Progression-free survival (PFS)	Through study completion, an average of 6 months
Duration of response (DOR)	Through study completion, an average of 6 months
Pharmacokinetics（serum concentration of ONO-7913）	Through study completion, an average of 6 months
Best overall response (BOR)	Through study completion, an average of 6 months
Percentage of change in the sum of tumor diameters of target lesions	Through study completion, an average of 6 months
Maximum percentage of change in the sum of tumor diameters of target lesions	Through study completion, an average of 6 months
Changes in tumor markers (CEA and CA19-9)	Through study completion, an average of 6 months
Time to response (TTR)	Through study completion, an average of 6 months
Pharmacokinetics（serum concentration of ONO-4538）	Through study completion, an average of 6 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026