Malignant Solid TumorPhase 1NCT00836888

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

A Phase 1 study testing ONO-4538 in people with Malignant Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

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

Official record

Search all trials

Trial summary

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Malignant Solid Tumor
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: 17 participants
Where: 1 siteJapan
Study dates: Jan 2009to Sep 2010
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

Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
ECOG Performance Status of 0-1
Life expectancy ≥ 3 months
Other inclusion criteria as specified in the study protocol

Who cannot join

History of severe hypersensitivity reactions to other antibodies.
Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
Other exclusion criteria as specified in the study protocol

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kanto Region, Kanto

Other trials in Japan

About this study

Official title: ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

Conditions: Malignant Solid Tumor
Being tested: ONO-4538
Keywords: ONO-4538, MDX-1106, solid tumors

What participants receive

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

ONO-4538Biological
1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Study groups in NCT00836888
Study group	Role	What they receive
Cohort	Experimental	Not described Receives: Biological: ONO-4538

What is being measured

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

Cmax at Single Dose
Measured: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
AUClast at Single Dose
Measured: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
T1/2 at Single Dose
Measured: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Ceoi at Multiple Doses
Ceoi：Serum concentrations immediately after the end of continuous administration
Measured: day 15

Secondary outcomes (1)

Best Overall Response
Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure.
Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
Measured: up to study completion, every 4 weeks in principle

Timeline

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

Jan 2009Sep 2010

First posted4 Feb 2009 (estimated)
Study startJan 2009
Primary completionSep 2010

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.
Other trials for Malignant Solid TumorStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00836888
Sponsor's protocol ID: ONO-4538-01
Status last verified: Apr 2015
First submitted: 26 Jan 2009
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov

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

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 1
PAS-004 in Patients With Advanced Solid Tumors
RAS Mutation, NF1 Mutation

All Malignant Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT00836888
Acronym / sponsor ID: ONO-4538-01
Conditions: Malignant Solid Tumor
Keywords: ONO-4538, MDX-1106, solid tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Sep 2010 (actual)
First posted: 4 Feb 2009 (estimated)
Results: Posted 8 Oct 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cohort	Experimental	Biological: ONO-4538

Who may qualify

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

Key inclusion criteria (5 listed)

Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
ECOG Performance Status of 0-1
Life expectancy ≥ 3 months
Other inclusion criteria as specified in the study protocol

Key exclusion criteria (5 listed)

History of severe hypersensitivity reactions to other antibodies.
Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
Other exclusion criteria as specified in the study protocol

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-45381mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts	Biological	Cohort

Primary outcome

Cmax at Single Dose
Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
AUClast at Single Dose
Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
T1/2 at Single Dose
Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Ceoi at Multiple Doses
Time frame: day 15
Ceoi：Serum concentrations immediately after the end of continuous administration

1 secondary outcome

Best Overall Response
Time frame: up to study completion, every 4 weeks in principle

Results and safety

Results posted to the registry on 8 Oct 2020, 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 1mg/kg Cohorts	3	0
ONO-4538 3mg/kg Cohorts	5	2
ONO-4538 10mg/kg Cohorts	6	0
ONO-4538 20mg/kg Cohorts	3	0

Primary outcome: Cmax at Single Dose

Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation. Mean (Standard Deviation). Unit: μg/mL

Measure	ONO-4538 1mg/kg Cohorts n = 3	ONO-4538 3mg/kg Cohorts n = 5	ONO-4538 10mg/kg Cohorts n = 6	ONO-4538 20mg/kg Cohorts n = 3
Value	24.4 (4.5)	68.8 (10.9)	192 (36)	214 (68)

Primary outcome: AUClast at Single Dose

Measure	ONO-4538 1mg/kg Cohorts n = 3	ONO-4538 3mg/kg Cohorts n = 5	ONO-4538 10mg/kg Cohorts n = 6	ONO-4538 20mg/kg Cohorts n = 3
Value	4950 (580)	12300 (4500)	43900 (7200)	67400 (15500)

Primary outcome: T1/2 at Single Dose

Measure	ONO-4538 1mg/kg Cohorts n = 3	ONO-4538 3mg/kg Cohorts n = 5	ONO-4538 10mg/kg Cohorts n = 6	ONO-4538 20mg/kg Cohorts n = 3
Value	15 (0)	13 (7)	21 (11)	17 (9)

Primary outcome: Ceoi at Multiple Doses

Time frame: day 15. Mean (Standard Deviation). Unit: μg/mL

Measure	ONO-4538 1mg/kg Cohorts n = 3	ONO-4538 3mg/kg Cohorts n = 5	ONO-4538 10mg/kg Cohorts n = 6	ONO-4538 20mg/kg Cohorts n = 3
Value	29.3 (6.0)	101 (12)	270 (42)	286 (112)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All subjects treated with the study drug were followed up for at least 28 days after the last dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ONO-4538 1mg/kg Cohorts	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
ONO-4538 3mg/kg Cohorts	1 of 5 (20%)	5 of 5 (100%)	0 of 5
ONO-4538 10mg/kg Cohorts	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
ONO-4538 20mg/kg Cohorts	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Malignant Solid Tumor

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 1
PAS-004 in Patients With Advanced Solid Tumors
RAS Mutation, NF1 Mutation

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.

Ohyama Yukiya study director

Ono Pharmaceutical Co., Ltd.

1 site 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 Malignant Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.

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 5 inclusion and 5 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 8 Oct 2020). 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?

Cmax at Single Dose (time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation). The study lists 4 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 NCT00836888.

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 8 Oct 2020.