Relapsed or Refractory Lymphoma or Advanced Cancer
Conditions
Brief summary
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.
Interventions
DRUGTQ-B3525
TQ-B3525 p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed * ECOG PS≤1 * Adequate blood cell counts, kidney function and liver function * Patients should participate in the study voluntarily and sign informed consent
Exclusion criteria
* Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history * Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication * Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicities (DLT) | Baseline up to 28 days | DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria: 1. \>=Grade 3 of non-hematology toxicity 2. Grade 4 hematology toxicity |
| Maximum Tolerated Dose (MTD) | Baseline up to 28 days | MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was \< 33%. |
Countries
China
Contacts
Primary ContactHuaqing Wang, doctor
Outcome results
None listed