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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SHR0302 will be administered orally as tablet. SHR0302 treatment will be continued until disease progression or intolerant adverse reactions
Henan cancer hospital
Zhengzhou, Henan, China
RP2D
The RP2D is defined as the dose level chosen for phase II study, based on safety, tolerability, efficacy, collected during the dose escalation study of SHR0302.
Time frame: Up to 30 days after the first dose
Incidence and severity of AEs and SAEs
To evaluate the safety and tolerability of SHR0302 in patients with PTCL in terms of AEs and SAEs as Assessed by CTCAE v5.0
Time frame: The first dose until 30 days after last dose
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