A Study of TQ-B3525 on Tolerance and Pharmacokinetics

Phase 1

Recruiting

• Conditions: Relapsed or Refractory Lymphoma or Advanced Cancer
• Interventions: Drug: TQ-B3525

• Registration Number: NCT03510767
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-27
• Study Start: 2018-06-20
• Primary Completion: 2022-08-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3525	TQ-B3525	-

Primary Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (1)

People's Hospital of Tianjin; 🇨🇳 Tianjin, Tianjin, China