A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408079
• Other study ID #: TQB3558-?-01
• Status: Recruiting
• Phase: Phase 1
• Start date: June 25, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: June 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Zan Shen, Doctor
• Phone: 021-24058431
• Email: Sshenzzan[@]vip.sina.com
• 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 TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.

2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy =12 weeks.

3. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.

Exclusion Criteria:

• 1. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.

3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.

4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.

5. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.

7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.

8. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• TQB3558
TQB3558 is a kinase inhibitor of the TRK protein family.

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai

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.	Baseline up to 28 days
Primary	Adverse events (AE) and serious adverse events (SAE)	The occurrence of all adverse events (AE) and serious adverse events (SAE).	Baseline up to 28 days
Primary	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 96 weeks
Secondary	Tmax	To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration.	15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Secondary	Cmax	Cmax is the maximum plasma concentration of TQB3558 or metabolite(s).	15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Secondary	AUC0-t	To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity.	15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Secondary	CL/f	CL/f is total clearance rate for TQB3558.	15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Secondary	Disease control rate(DCR)	Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).	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