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

Relapsed/Refractory Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04412577
• Other study ID #: TQB3473-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: October 12, 2020
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Peng Liu, Doctor
• Phone: 021-60267405
• Email: Liu.peng[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Neoplasms
• Relapsed/Refractory Hematological Malignancies

Intervention

Drug:
• TQB3473
TQB3473 tablets administered orally once. Then TQB3473 tablets administered orally, once daily in 28-day cycle after 3 days of first administration.

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.	up to 31 days
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Overall response rate (ORR)	Percentage of subjects achieving complete response (CR) and partial response (PR).	up to 96 weeks
Secondary	Progression-free survival (PFS)	PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.	up to 96 weeks
Secondary	Duration of Response (DOR)	DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.	up to 96 weeks