A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3473 Tablets

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country57 target enrollmentOctober 12, 2020

ConditionsRelapsed/Refractory Hematological Malignancies

InterventionsTQB3473

DrugsTQB3473

Overview

Phase: Phase 1
Intervention: TQB3473
Conditions: Relapsed/Refractory Hematological Malignancies
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 57
Locations: 2
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 12, 2020

End Date

June 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Understood and signed an informed consent form.
•Relapsed or refractory malignant hematological tumors.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
•Has at least one measurable lesion.
•Adequate organ system function.
•Patients need to adopt effective methods of contraception.

Exclusion Criteria

•Severe hypersensitivity to the drug or ingredients.
•Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose.
•Has received spleen tyrosine kinase (SYK) inhibitors.
•Has to use ≥ 10 mg/day glucocorticoid prednisone.
•Has received BTK inhibitors and PI3K inhibitors before the first dose.
•Has received allogeneic hematopoietic stem cell transplantation.
•Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose.
•Has any acute or chronic gastrointestinal diseases.
•Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis.
•Intermediate-risk or high-risk myelodysplastic syndrome.

Arms & Interventions

TQB3473 tablets

TQB3473 tablets administered once daily in 28-day cycle .

Intervention: TQB3473

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: up to 31 days

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

Secondary Outcomes

Tmax(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.)
Cmax Cmax(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.)
AUC0-t(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.)
Overall response rate (ORR)(up to 96 weeks)
Progression-free survival (PFS)(up to 96 weeks)
Duration of Response (DOR)(up to 96 weeks)