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A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies

Primary Purpose

Relapsed/Refractory Hematological Malignancies

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB3473
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Hematological Malignancies

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-1.Understood and signed an informed consent form. 2. Relapsed or refractory malignant hematological tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

4. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception.

Exclusion Criteria:

  • 1. Severe hypersensitivity to the drug or ingredients. 2. Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose.

    3. Has received spleen tyrosine kinase (SYK) inhibitors. 4. Has to use ≥ 10 mg/day glucocorticoid prednisone. 5. Has received BTK inhibitors and PI3K inhibitors before the first dose. 6. Has received allogeneic hematopoietic stem cell transplantation. 7. Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose.

    8. Has any acute or chronic gastrointestinal diseases. 9. Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis.

    10. Intermediate-risk or high-risk myelodysplastic syndrome. 11. Pregnancy and lactation women. 12. Has any serious and/or uncontrollable disease. 13. Has active autoimmune disease and received immunosuppressive therapy. 14. Has a history of neurological or mental disorders. 15. Has uncontrollable systemic bacterial, fungal or viral active infections 16. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 17. Has other malignancies. 18. Has received surgery within 4 weeks before the first administration. 19. Has participated in any other clinical trials. 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Sites / Locations

  • Henan Cancer HospitalRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQB3473 tablets

Arm Description

TQB3473 tablets administered once daily in 28-day cycle .

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.

Secondary Outcome Measures

Tmax
Cmax Cmax
AUC0-t
Overall response rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Full Information

First Posted
May 28, 2020
Last Updated
March 29, 2021
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04412577
Brief Title
A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies
Official Title
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3473 Tablets
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Hematological Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB3473 tablets
Arm Type
Experimental
Arm Description
TQB3473 tablets administered once daily in 28-day cycle .
Intervention Type
Drug
Intervention Name(s)
TQB3473
Intervention Description
TQB3473 tablets administered orally once. Then TQB3473 tablets administered orally, once daily in 28-day cycle after 3 days of first administration.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Time Frame
up to 31 days
Secondary Outcome Measure Information:
Title
Tmax
Time Frame
30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
Title
Cmax Cmax
Time Frame
30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
Title
AUC0-t
Time Frame
30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
Title
Overall response rate (ORR)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time Frame
up to 96 weeks
Title
Progression-free survival (PFS)
Description
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time Frame
up to 96 weeks
Title
Duration of Response (DOR)
Description
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time Frame
up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -1.Understood and signed an informed consent form. 2. Relapsed or refractory malignant hematological tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks. 4. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception. Exclusion Criteria: 1. Severe hypersensitivity to the drug or ingredients. 2. Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose. 3. Has received spleen tyrosine kinase (SYK) inhibitors. 4. Has to use ≥ 10 mg/day glucocorticoid prednisone. 5. Has received BTK inhibitors and PI3K inhibitors before the first dose. 6. Has received allogeneic hematopoietic stem cell transplantation. 7. Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose. 8. Has any acute or chronic gastrointestinal diseases. 9. Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis. 10. Intermediate-risk or high-risk myelodysplastic syndrome. 11. Pregnancy and lactation women. 12. Has any serious and/or uncontrollable disease. 13. Has active autoimmune disease and received immunosuppressive therapy. 14. Has a history of neurological or mental disorders. 15. Has uncontrollable systemic bacterial, fungal or viral active infections 16. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 17. Has other malignancies. 18. Has received surgery within 4 weeks before the first administration. 19. Has participated in any other clinical trials. 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Liu, Doctor
Phone
021-60267405
Email
Liu.peng@zs-hospital.sh.cn
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Song, Doctor
Email
songyongping@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yongping Song, Doctor
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Liu, Doctor
Phone
021-60267405
Email
Liu.peng@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Peng Liu, Doctor

12. IPD Sharing Statement

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A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies

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