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NCT Number: 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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients are unable to swallow oral medications
  • Patients with severe complication

Treatment and study plan

ONO-7475

Drug

Specified dose on specified days

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab

Nab-paclitaxel

Drug

Specified dose on specified days

Gemcitabine

Drug

Specified dose on specified days

Primary outcomes

  1. Dose-limiting toxicities (DLT)

    Time frame: 28 days

  2. Adverse event (AE)

    Time frame: Up to 28 days after the last dose

Secondary outcomes

  1. Pharmacokinetics (Plasma concentration of ONO-7475)

    Time frame: Up to Cycle16

  2. Pharmacokinetics (Plasma concentration of ONO-4538)

    Time frame: Through study completion, an average of 6 months

  3. Anti-ONO-4538 antibody

    Time frame: Through study completion, an average of 6 months

  4. Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 6 months

  5. Disease Control Rate (DCR)

    Time frame: Through study completion, an average of 6 months

  6. Overall Survival (OS)

    Time frame: Through study completion, an average of 1 year

  7. Progression-Free Survival (PFS)

    Time frame: Through study completion, an average of 6 months

  8. Duration of Response (DOR)

    Time frame: Through study completion, an average of 6 months

  9. Time to Response (TTR)

    Time frame: Through study completion, an average of 6 months

  10. Best Overall Response (BOR)

    Time frame: Through study completion, an average of 6 months

  11. Percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 6 months

  12. Maximum percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 6 months

  13. CEA

    Time frame: Through study completion, an average of 6 months

  14. CA19-9

    Time frame: Through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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