ONO-4538 Phase I Study in Patients With Solid Tumor

ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor

The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors; Recurrent Solid Tumors
• Intervention / Treatment: Drug: ONO-4538

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul Clinical Site 101
  • Seoul, Korea, Republic of
    • Seoul Clinical Site 102
  • Seoul, Korea, Republic of
    • Seoul Clinical Site 103
  • Seoul, Korea, Republic of
    • Seoul Clinical Site 104
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Seongnam-si Clinical Site 105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female ≥ 20 years of age
• Histologically or cytologically confirmed solid tumor
• Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
• ECOG Performance Status is 0 to 1

Exclusion Criteria:

• Current or prior severe hypersensitivity to another antibody product
• Multiple primary cancers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4538 1mg/kg; ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose	Drug: ONO-4538
Experimental: ONO-4538 3mg/kg; ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose	Drug: ONO-4538
Experimental: ONO-4538 10mg/kg; ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose	Drug: ONO-4538

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Outcome: Cmax of ONO-4538	Cmax was the maximum serum concentration of ONO-4538 after the single administration.	3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
PK Outcome: Tmax of ONO-4538	Tmax was the time to reach the Cmax.	3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
AUC21day	AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).	3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
AUCinf	AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.	3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
T1/2	T1/2 was the elimination half-life of serum concentration of ONO-4538.	3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome: The Number of Subjects With Overall Adverse Events	Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product.	3 weeks: from the start of administration to the end of treatment phase.
Safety Outcome: The Number of Deaths	Number of subjects with TEAEs leading to death.	3 weeks: from the start of administration to the end of treatment phase.

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Publications and helpful links

General Publications

• Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimated): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: ONO-4538-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES