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

Phase 1

Recruiting

• Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Interventions: Drug: ONO-4685

• Registration Number: NCT06547528
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2029-01-31
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. 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)

2. 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

3. ECOG PS 0~2

4. Life expectancy of at least 3 months

Exclusion Criteria

1. Patients with severe complications.
2. Patients with multiple cancers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4685	ONO-4685	-

Primary Outcome Measures

Name	Time	Method
Pulse rate	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
Dose-limiting toxicities(DLT)	Up to 3 Weeks
Incidence and severity of AEs and SAEs	Through study completion, an average of 1 year
Body temperature	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(QRS)	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
Systolic/diastolic blood pressure	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(PR interval)	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(corrected QT intervals [QTcF, QTcB])	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
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
Time to response (TTR)	Through study completion, an average of 1 year
Overall response rate (ORR)	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
Pharmacokinetics(T1/2)	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(Ctrough)	Through study completion, an average of 1 year
Anti-ONO-4685 antibody	Through study completion, an average of 1 year

Trial Locations

Locations (14)

Aichi Cancer Center 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

Kumamoto University Hospital; 🇯🇵 Kumamoto-shi, Kumamoto, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo-shi, Hokkaido, Japan

University Hospital Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto-shi, Kyoto, Japan

Cancer Institute Hospital of JFCR; 🇯🇵 Koto-ku, Tokyo, Japan

Okayama University Hospital; 🇯🇵 Okayama-shi, Okayama, Japan

Kindai University Hospital; 🇯🇵 Osaka Sayama-shi, Osaka, Japan

Nagoya University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Tokai University Hospital; 🇯🇵 Isehara-shi, Kanagawa, Japan

Osaka University Hospital; 🇯🇵 Osaka-fu, Osaka, Japan

Tohoku University Hospital; 🇯🇵 Sendai-shi, Miyagi, Japan