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

NCT06547528 · Ono Pharmaceutical Co., Ltd.
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Official title
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)
About this study
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Eligibility criteria
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
Enrollment target: 108 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-01
Estimated completion: 2029-04-30
Last updated: 2025-06-03
Interventions
Drug: ONO-4685
Primary outcomes
  • 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)
Sponsor
Ono Pharmaceutical Co., Ltd. · industry
Contacts & investigators
ContactNorth America Clinical Trial Support Desk · contact · clinical_trial@ono-pharma.com · +18665877745(Toll-Free)
ContactInternational Clinical Trial Support Desk · contact · clinical_trial@ono-pharma.com · +17162141777(Standard)
InvestigatorProject Leader · study_director, Ono Pharmaceutical Co., Ltd.
All locations (14)
Aichi Cancer Center HospitalRecruiting
Nagoya, Aichi-ken, Japan
Nagoya University HospitalRecruiting
Nagoya, Aichi-ken, Japan
Akita University HospitalRecruiting
Akita, Akita, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa-shi, Chiba, Japan
Kyushu University HospitalRecruiting
Fukuoka, Fukuoka, Japan
Hokkaido University HospitalRecruiting
Sapporo, Hokkaido, Japan
Tokai University HospitalRecruiting
Isehara-shi, Kanagawa, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Kumamoto, Japan
University Hospital Kyoto Prefectural University of MedicineRecruiting
Kyoto, Kyoto, Japan
Tohoku University HospitalRecruiting
Sendai, Miyagi, Japan
Okayama University HospitalRecruiting
Okayama, Okayama-ken, Japan
Kindai University HospitalRecruiting
Osaka Sayama-shi, Osaka, Japan
Osaka University HospitalNot Yet Recruiting
Osaka-fu, Osaka, Japan
Cancer Institute Hospital of JFCRRecruiting
Koto-ku, Tokyo, Japan