A Study of TQ-B3525 on Tolerance and Pharmacokinetics
A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics
1 other identifier
interventional
60
1 country
1
Brief Summary
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedApril 14, 2023
April 1, 2023
4.2 years
April 18, 2018
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-Limiting Toxicities (DLT)
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
Baseline up to 28 days
Maximum Tolerated Dose (MTD)
MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was \< 33%.
Baseline up to 28 days
Study Arms (1)
TQ-B3525
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, 300121, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huaqing Wang, doctor
People's Hospital of Tianjin Tianjin,China,300121
- STUDY CHAIR
Wenqi Jiang, doctor
Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China, 510060
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2018
First Posted
April 27, 2018
Study Start
June 20, 2018
Primary Completion
August 15, 2022
Study Completion
August 1, 2024
Last Updated
April 14, 2023
Record last verified: 2023-04