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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06538207

Enrollment

46

Registered

2024-08-05

Start date

2021-01-13

Completion date

2025-01-30

Last updated

2025-02-06

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

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.

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

DRUGGemcitabine

Specified dose on specified days

DRUGNab-Paclitaxel

Specified dose on specified days

Sponsors

Ono Pharmaceutical Co. Ltd

Lead SponsorINDUSTRY

Study design

Allocation

NON_RANDOMIZED

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\. 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Overall response rate (ORR)	Up to 2 years
Disease control rate (DCR)	Up to 2 years
Overall survival (OS)	Up to 2 years
Progression-free survival (PFS)	Up to 2 years
Duration of response (DOR)	Up to 2 years
Pharmacokinetics (Plasma concentration for ONO-4578)	Up to 28 days after the last dose
Best overall response (BOR)	Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Changes in tumor markers (CEA and CA19-9)	Up to 2 years
Time to response (TTR)	Up to 2 years
Pharmacokinetics (Serum concentration for ONO-4538)	Up to 28 days after the last dose

Countries

Japan

Outcome results

None listed

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