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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

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 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as monoclonal antibodies (e.g., rituximab), specifically target cancer cell markers, minimizing damage to normal cells. Immunotherapy, including CAR-T cell therapy, harnesses the patient's immune system to recognize and destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment with manageable side effects, improving outcomes and quality of life.

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
~36 spots leftby Dec 2027