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A Study of TQ-B3525 on Tolerance and Pharmacokinetics

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03510767
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
20.9
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics
Actual Study Start Date :
Apr 3, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: TQ-B3525

Drug: TQ-B3525
TQ-B3525 p.o. qd

Outcome Measures

Primary Outcome Measures

  1. Dose-Limiting Toxicities (DLT) [Baseline up to 28 days]

    DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria: >=Grade 3 of non-hematology toxicity Grade 4 hematology toxicity

  2. 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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 People's Hospital of Tianjin Tianjin Tianjin China 300121

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03510767
Other Study ID Numbers:
  • TQ-B3525-I-01
First Posted:
Apr 27, 2018
Last Update Posted:
Apr 27, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 27, 2018