A Study of TQ-B3525 on Tolerance and Pharmacokinetics

April 12, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics

To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huaqing Wang, doctor
  • Phone Number: +86-022-022-2757483
  • Email: huaqingw@163.com

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Recruiting
        • People's Hospital of Tianjin
        • Contact:
          • Huaqing Wang, doctor
          • Phone Number: +86-022-022-2757483
          • Email: huaqingw@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQ-B3525
Drug: TQ-B3525
TQ-B3525 p.o. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicities (DLT)
Time Frame: 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
Baseline up to 28 days
Maximum Tolerated Dose (MTD)
Time Frame: Baseline up to 28 days
MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was < 33%.
Baseline up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2018

Primary Completion (Actual)

August 15, 2022

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TQ-B3525-I-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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