This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
1.Patients fully understand and sign ICF, voluntarily participate in the study, and able to follow and complete all study procedures.
2.Aged 18-80 years (including upper and lower limits), male or female.
Surgical excision is confirmed by histology or cytology can't or metastatic patients with advanced solid tumor;
Patients with relapsed or refractory hematologic malignancies
1. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risks judged by investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy);
2. Clinically symptomatic parenchymal or leptomeningeal metastases that were judged by the investigator to be ineligible for enrollment and, for AML patients, known central nervous system (CNS) involvement
Nitrosourea or mitomycin C within 6 weeks before first use of study drug;
Oral fluorouracils and small-molecule targeted agents are administered 2 weeks before first use of the study drug or within the five half-lives of the drug, whichever is longer;
Single group
YY201
DrugOral administration under fasting state.
Dose limiting toxicity
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0)
Maximum tolerated dose
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of YY201 . The type, frequency and severity of TEAE will be evaluated during the treatment of YY201 .
Recommended Dose for Phase II Clinical Studies (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of YY201.
Cmax
Maximum serum concentration (Cmax) of YY201 will be investigated.
Tmax
Time to maximum serum concentration (Tmax) of YY201 will be investigated.
T1/2
Half-life (T1/2) of YY201 will be investigated.
Duration of Response(DoR)
The time from the patient's first objective response to the patient's disease recurrence, progression, or death.
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