Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Method of Administration: Single dose period: Single oral administration under fasting state; Multiple dose period: Oral administration under fasting state, QD.

YY201

Ye Guo

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.

This study includes a dose escalation phase and a dose expansion phase. In the dose escalation phase the MTD and/or RP2D of YY201 will be determined and in the dose expansion phase the anti-tumor efficacy of YY201 will be evaluated in patients with relapsed⁄refractory hematological malignancies. The two-phase study will assess the preliminary anti-tumor efficacy , safety, tolerability, and PK profile of YY201 .

An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies

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)

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.

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 .

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.

Maximum serum concentration (Cmax) of YY201 will be investigated.

Time to maximum serum concentration (Tmax) of YY201 will be investigated.

Half-life (T1/2) of YY201 will be investigated.

The time from the patient's first objective response to the patient's disease recurrence, progression, or death.

The time from the first dose of YY201 to the first occurrence of objective response.

The time from start date of study drug to death due to any cause.

Spots Global Cancer Trial Database for yy201

Every month we try and update this database with for yy201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yy201

Every month we try and update this database with for yy201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yy201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.