Clinical trial NCT06547528: A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Dose-limiting toxicities(DLT)
timeFrame: Up to 3 Weeks
measure: Incidence and severity of AEs and SAEs
timeFrame: Through study completion, an average of 1 year
measure: Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities
timeFrame: Through study completion, an average of 1 year
measure: Body temperature
timeFrame: Through study completion, an average of 1 year
measure: Pulse rate
timeFrame: Through study completion, an average of 1 year
measure: Systolic/diastolic blood pressure
timeFrame: Through study completion, an average of 1 year
measure: Change of weight during the trial period
timeFrame: Through study completion, an average of 1 year
measure: Chest X-ray test
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(pulse rate)
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(RR)
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(QT interval)
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB])
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(PR interval)
timeFrame: Through study completion, an average of 1 year
measure: ECG parameters by 12 lead ECG(QRS)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Best overall response (BOR)
timeFrame: Through study completion, an average of 1 year
measure: Overall response rate (ORR)
timeFrame: Through study completion, an average of 1 year
measure: Complete response rate (CRR)
timeFrame: Through study completion, an average of 1 year
measure: Duration of response (DOR)
timeFrame: Through study completion, an average of 1 year
measure: Progression Free Survival(PFS)
timeFrame: Through study completion, an average of 1 year
measure: Time to response (TTR)
timeFrame: Through study completion, an average of 1 year
measure: Overall Survival(OS)
timeFrame: Through study completion, an average of 1 year
measure: The percent change of tumor volume
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(Cmax)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(Tmax)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(AUC)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(Ceoi)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(T1/2)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics(Ctrough)
timeFrame: Through study completion, an average of 1 year
measure: Volume of distribution(Vd)
timeFrame: Through study completion, an average of 1 year
measure: clearance(CL)
timeFrame: Through study completion, an average of 1 year
measure: Anti-ONO-4685 antibody
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osaka Sayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Osaka-fu
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: