Advanced Solid TumorsPhase 1NCT02261285

ONO-4538 Phase I Study in Patients With Solid Tumor

A Phase 1 study testing ONO-4538 in people with Advanced Solid Tumors and Recurrent Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Advanced Solid Tumors, Recurrent Solid Tumors
What is being tested?: ONO-4538
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 5 sitesSouth Korea
Study dates: Oct 2014to Dec 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Korea5 sites

Seongnam-si Clinical Site 105
Seongnam-si, Gyeonggi-do
Seoul Clinical Site 101
Seoul
Seoul Clinical Site 102
Seoul
Seoul Clinical Site 103
Seoul
Seoul Clinical Site 104
Seoul

Other trials in South Korea

About this study

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

Conditions: Advanced Solid Tumors, Recurrent Solid Tumors
Being tested: ONO-4538

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ONO-4538Drug

Study groups in NCT02261285
Study group	Role	What they receive
ONO-4538 1mg/kg	Experimental	ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose Receives: Drug: ONO-4538
ONO-4538 3mg/kg	Experimental	ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose Receives: Drug: ONO-4538
ONO-4538 10mg/kg	Experimental	ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose Receives: Drug: ONO-4538

What is being measured

The primary outcome is the main question the study is designed to answer.

PK Outcome: Cmax of ONO-4538
Cmax was the maximum serum concentration of ONO-4538 after the single administration.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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 outcomes (2)

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.
Measured: 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.
Measured: 3 weeks: from the start of administration to the end of treatment phase.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Dec 2014

First posted10 Oct 2014 (estimated)
Study startOct 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Increase the dose sequentially.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02261285
Sponsor's protocol ID: ONO-4538-13
Status last verified: May 2024
First submitted: 30 Sep 2014
Last updated: 6 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 29158363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor
ClinicalTrials.gov ID: NCT02261285
Acronym / sponsor ID: ONO-4538-13
Conditions: Advanced Solid Tumors, Recurrent Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 10 Oct 2014 (estimated)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Increase the dose sequentially.

Arm	Type	Receives
ONO-4538 1mg/kg	Experimental	Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose
ONO-4538 3mg/kg	Experimental	Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose
ONO-4538 10mg/kg	Experimental	Drug: ONO-4538ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ONO-4538	Drug	ONO-4538 10mg/kg, ONO-4538 1mg/kg, ONO-4538 3mg/kg

Primary outcome

PK Outcome: Cmax of ONO-4538
Time frame: 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.
Cmax was the maximum serum concentration of ONO-4538 after the single administration.
PK Outcome: Tmax of ONO-4538
Time frame: 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.
Tmax was the time to reach the Cmax.
AUC21day
Time frame: 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 was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).
AUCinf
Time frame: 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 was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.
T1/2
Time frame: 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 was the elimination half-life of serum concentration of ONO-4538.

2 secondary outcomes

Safety Outcome: The Number of Subjects With Overall Adverse Events
Time frame: 3 weeks: from the start of administration to the end of treatment phase.
Safety Outcome: The Number of Deaths
Time frame: 3 weeks: from the start of administration to the end of treatment phase.

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ONO-4538 1 mg/kg	6	6
ONO-4538 3 mg/kg	6	6
ONO-4538 10 mg/kg	6	5

Primary outcome: PK Outcome: Cmax of ONO-4538

Time frame: 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.. Mean (Standard Deviation). Unit: µg/mL

Measure	ONO-4538 1 mg/kg n = 6	ONO-4538 3 mg/kg n = 6	ONO-4538 10 mg/kg n = 6
Value	26.0 (4.29)	64.3 (22.5)	242.0 (66.7)

Primary outcome: PK Outcome: Tmax of ONO-4538

Measure	ONO-4538 1 mg/kg n = 6	ONO-4538 3 mg/kg n = 6	ONO-4538 10 mg/kg n = 6
Value	3.02 (1.07 to 9.00)	3.00 (1.00 to 8.78)	2.99 (1.00 to 8.62)

Primary outcome: AUC21day

Measure	ONO-4538 1 mg/kg n = 6	ONO-4538 3 mg/kg n = 6	ONO-4538 10 mg/kg n = 5
Value	5110 (952)	12200 (2060)	38700 (14200)

Primary outcome: AUCinf

Measure	ONO-4538 1 mg/kg n = 6	ONO-4538 3 mg/kg n = 6	ONO-4538 10 mg/kg n = 5
Value	9180 (3140)	22800 (10000)	68100 (34700)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks: from the start of administration to the end of treatment phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ONO-4538 1 mg/kg	1 of 6 (16.7%)	5 of 6 (83.3%)	1 of 6
ONO-4538 3 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
ONO-4538 10 mg/kg	1 of 6 (16.7%)	5 of 6 (83.3%)	1 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29158363Lee 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mitsunobu Tanimoto study director

Ono Pharmaceutical Co., Ltd.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONO-4538 in people with Advanced Solid Tumors and Recurrent Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK Outcome: Cmax of ONO-4538 (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.