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Trial Title:
Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma
NCT ID:
NCT05900089
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR0302
Description:
SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until
disease progression or intolerant adverse reactions
Arm group label:
SHR0302 Group A
Arm group label:
SHR0302 Group B
Arm group label:
SHR0302 Group C
Summary:
This is a non-randomized, open-label, Phase 1b clinical study to evaluate the safety,
tolerability and anti-tumor efficacy of SHR0302 as monotherapy in patients with
relapsed/refractory peripheral T/NK cell lymphoma. Around 7-18 patients will be
subsequently enrolled into 3 different dose ascending cohorts. Additional 12-18 patients
may be enrolled to further explore a selected dose defined by dose escalation cohorts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18;
2. Pathologically confirmed T or NK cell lymphoma at the enrolling institution;
3. Measurable disease;
4. Relapse or refractory disease after at least 1 systemic therapy;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 ；
6. With a life expectancy of ≥12 weeks;
7. Adequate bone marrow reserve and organ system functions;
8. Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within
seven days before the first medication and the results are negative. WOBCP or men
and their WOBCP partners should agree to take effective contraceptive measures from
the signing of ICF until 180 days after the last dose of the study drug is used;
9. Willing to provide written informed consent.
Exclusion Criteria:
1. Patient has undergone an allogeneic stem cell transplant. Or patient had autologous
stem cell transplant within 6 months;
2. Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade
1 from previous anti-cancer therapy (except alopecia);
3. Central nervous system (CNS) or leptomeningeal lymphoma;
4. received any antitumor therapy within 28 days prior to the first drug use, or the
first dose was given within five half-lives of the previous antitumor drug,
whichever is shorter;
5. Major surgical procedures were performed within 28 days before the first dose of
study treatment, or surgery was planned during the study period;
6. Diagnosed with any other malignancies ≤5 years prior to the first dose, early tumors
cured after radical treatment were evaluated by PI and considered for exclusion or
not;
7. History of psychotropic substance abuse or drug use;
8. Previous history of allergy to the investigational drug or its excipients;
9. Severe cardiovascular disease;
10. Significant impairment of lung function;
11. Active infections;
12. Pregnant or lactation;
13. Known GI disease or GI procedure that could interfere with the oral absorption of
oral medications, including not well controlled refractory nausea, vomiting, chronic
gastrointestinal disorders, or capsule swallowing difficulties, or prior surgical
resection of intestinal segments;
14. Concomitant disease or condition that could interfere with the conduct of the study,
or that would, in the opinion of the investigator, pose an unacceptable risk to the
subject in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan cancer hospital
Address:
City:
Zhengzhou
Country:
China
Start date:
May 30, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900089
