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Monoclonal Antibodies

ONO-7018 for Non-Hodgkin's Lymphoma and Chronic B-Cell Leukemia

Phase 1

Recruiting

Research Sponsored by Ono Pharmaceutical Co. Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test a new drug's safety and effectiveness in people. It has two parts and will be conducted at multiple sites.

Who is the study for?

This trial is for adults over 18 with certain types of blood cancers (NHL or CLL) that have come back or haven't responded to treatment, and who don't have other good treatment options. They should be fairly active (ECOG 0-2), able to swallow tablets, and not have serious medical issues that could affect the study.Check my eligibility

What is being tested?

ONO-7018 is being tested in this first-in-human study which has two parts: finding the right dose and then seeing how well it works at that dose. It's an open-label study, meaning everyone knows they're getting ONO-7018, and it's given across multiple centers.See study design

What are the potential side effects?

Since ONO-7018 is new, its side effects aren't fully known yet. However, participants will be closely monitored for any adverse reactions throughout the trial phases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimate of Maximum Tolerated Dose (MTD)

Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Secondary outcome measures

Antitumor Activity of ONO-7018 (Duration of Response [DOR])

Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])

Antitumor Activity of ONO-7018 (Overall Survival [OS])

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion Phase (Part 2)Experimental Treatment1 Intervention

Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.

Group II: Dose Escalation Phase (Part 1)Experimental Treatment1 Intervention

Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor

154 Previous Clinical Trials

94,469 Total Patients Enrolled

Takeyuki IwataStudy DirectorOno Pharmaceutical Co. Ltd

Project LeaderStudy DirectorOno Pharma USA Inc

12 Previous Clinical Trials

2,559 Total Patients Enrolled

Media Library

ONO-7018 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05515406 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Dose Escalation Phase (Part 1), Dose Expansion Phase (Part 2)

Non-Hodgkin's Lymphoma Clinical Trial 2023: ONO-7018 Highlights & Side Effects. Trial Name: NCT05515406 — Phase 1

ONO-7018 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515406 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still recruiting participants?

"According to clinicaltrials.gov, this trial is actively seeking participants. It was originally posted on February 13th of 2023 and has most recently been updated as of February 15th of the same year."

Answered by AI

Has the Dose Expansion Phase (Part 2) of this treatment been given regulatory approval?

"The amount of clinical data available for Dose Expansion Phase (Part 2) is limited, so it was rated a 1 on our team's scale. This indicates that this trial has only reached the initial phase in demonstrating efficacy and safety."

Answered by AI

What is the aggregate amount of participants included in this experiment?

"Yes, the information on clinicaltrials.gov confirms that this research is actively looking for participants. This trial was posted online on February 13th 2023 and latest updated two days later. Currently 54 individuals need to be recruited from 9 varied sites."

Answered by AI

How many medical facilities have been chosen to administer this experiment?

"Patients can access this trial at 9 different sites such as Emory University Hospital in Atlanta, AMR Kansas City in Kansas City and Summit Medical Group in Florham Park. An additional 6 locations are also available for patients to receive the treatment."

Answered by AI

What are the essential aims of this research endeavor?

"The study's sponsor, Ono Pharmaceutical Co. Ltd., is basing their primary outcome measure on the Maximum Tolerated Dose (MTD), which will be estimated over an average one-year interval. Additionally, they'll also evaluate secondary outcomes such as Antitumor Activity of ONO-7018 through Overall Response Rate (ORR) and Progression Free Survival (PFS). Lastly, they intend to assess overall survival in relation to this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

2023. "A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515406.

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