A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
NCT Number: NCT06547528
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Interventions: DRUG: ONO-4685
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2029-04-30
Locations: Aichi Cancer Center Hospital, Nagoya-shi, Aichi, Japan|Nagoya University Hospital, Nagoya-shi, Aichi, Japan|Akita University Hospital, Akita-shi, Akita, Japan|National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan|Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan|Tokai University Hospital, Isehara-shi, Kanagawa, Japan|Kumamoto University Hospital, Kumamoto-shi, Kumamoto, Japan|University Hospital Kyoto Prefectural University of Medicine, Kyoto-shi, Kyoto, Japan|Tohoku University Hospital, Sendai-shi, Miyagi, Japan|Okayama University Hospital, Okayama-shi, Okayama, Japan|Kindai University Hospital, Osaka Sayama-shi, Osaka, Japan|Osaka University Hospital, Osaka-fu, Osaka, Japan|Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan

Summary:
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

Primary Outcome Measures: Dose-limiting toxicities(DLT), Up to 3 Weeks|Incidence and severity of AEs and SAEs, Through study completion, an average of 1 year|Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities, Through study completion, an average of 1 year|Body temperature, Through study completion, an average of 1 year|Pulse rate, Through study completion, an average of 1 year|Systolic/diastolic blood pressure, Through study completion, an average of 1 year|Change of weight during the trial period, Through study completion, an average of 1 year|Chest X-ray test, Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(pulse rate), Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(RR), Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(QT interval), Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB]), Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(PR interval), Through study completion, an average of 1 year|ECG parameters by 12 lead ECG(QRS), Through study completion, an average of 1 year
Secondary Outcome Measures: Best overall response (BOR), Through study completion, an average of 1 year|Overall response rate (ORR), Through study completion, an average of 1 year|Complete response rate (CRR), Through study completion, an average of 1 year|Duration of response (DOR), Through study completion, an average of 1 year|Progression Free Survival(PFS), Through study completion, an average of 1 year|Time to response (TTR), 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(Cmax), 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(Ceoi), 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|Volume of distribution(Vd), Through study completion, an average of 1 year|clearance(CL), Through study completion, an average of 1 year|Anti-ONO-4685 antibody, Through study completion, an average of 1 year