An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 108
- Locations
- 14
- Primary Endpoint
- Pulse rate
Study Overview
Brief Summary
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
- •Peripheral T-cell lymphoma(PTCL)
- •Angioimmunoblastic T-cell lymphoma(AITL)
- •Peripheral T-cell lymphoma, NOS(PTCL-NOS)
- •Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
- •Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
- •Mycosis fungoides(MF)
- •Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
- •Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
- •ECOG PS 0~2
- •Life expectancy of at least 3 months
Exclusion Criteria
- •Patients with severe complications.
- •Patients with multiple cancers.
Arms & Interventions
ONO-4685
Intervention: ONO-4685 (Drug)
Outcomes
Primary Outcomes
Pulse rate
Time Frame: Through study completion, an average of 1 year
Change of weight during the trial period
Time Frame: Through study completion, an average of 1 year
Chest X-ray test
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QT interval)
Time Frame: Through study completion, an average of 1 year
Dose-limiting toxicities(DLT)
Time Frame: Up to 3 Weeks
Incidence and severity of AEs and SAEs
Time Frame: Through study completion, an average of 1 year
Body temperature
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(QRS)
Time Frame: Through study completion, an average of 1 year
Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
Time Frame: Through study completion, an average of 1 year
Systolic/diastolic blood pressure
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(RR)
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(PR interval)
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(pulse rate)
Time Frame: Through study completion, an average of 1 year
ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])
Time Frame: Through study completion, an average of 1 year
Secondary Outcomes
- Best overall response (BOR)(Through study completion, an average of 1 year)
- Progression Free Survival(PFS)(Through study completion, an average of 1 year)
- Duration of response (DOR)(Through study completion, an average of 1 year)
- Volume of distribution(Vd)(Through study completion, an average of 1 year)
- Overall response rate (ORR)(Through study completion, an average of 1 year)
- Time to response (TTR)(Through study completion, an average of 1 year)
- clearance(CL)(Through study completion, an average of 1 year)
- Complete response rate (CRR)(Through study completion, an average of 1 year)
- Pharmacokinetics(Cmax)(Through study completion, an average of 1 year)
- Pharmacokinetics(Ceoi)(Through study completion, an average of 1 year)
- Overall Survival(OS)(Through study completion, an average of 1 year)
- The percent change of tumor volume(Through study completion, an average of 1 year)
- Pharmacokinetics(Tmax)(Through study completion, an average of 1 year)
- Pharmacokinetics(AUC)(Through study completion, an average of 1 year)
- Pharmacokinetics(T1/2)(Through study completion, an average of 1 year)
- Pharmacokinetics(Ctrough)(Through study completion, an average of 1 year)
- Anti-ONO-4685 antibody(Through study completion, an average of 1 year)