A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title:

A Phase I, Open-label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128085
• Other study ID #: TQB3804-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2019
• Est. completion date: October 2021

Study information

• Verified date: December 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Wu yilong, Doctor
• Phone: 020-83877557
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3804 in patients with advanced malignant tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Understood and signed an informed consent form. 2. 18 and 70 years old. 3. Histologically or cytologically confirmed advanced malignant tumor. 4. Has EGFR mutations.

5. Life expectancy =12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

7.Adequate organ system function. 8.At least one measurable lesion.

Exclusion Criteria:

• 1.Hypersensitivity to TQB3804 or its excipient. 2. Has diagnosed and/or treated additional malignancy within 5 years with the exception of cured carcinoma in situ of the cervix?intramucosal carcinoma of gastrointestinal tract?breast and non-melanoma skin cancers and superficial bladder tumors.

3.Has interstitial pneumonia. 4.Brain metastases with symptom . 5.Has currently uncontrollable congestive heart failure. 6.Has history of arterial thromboembolism within 6 months. 7.Has any bleeding tendency or coagulopathy within 6 months. 8.Has skin toxicity = grade 2 within 4 weeks. 9.Has serious gastrointestinal diseases within 4 weeks. 10.Has received any major surgery within 4 weeks. 11.Participated in other clinical trials within 4 weeks. 12.Has active viral, bacterial and fungal infections within 4 weeks. 13.Has received any cancer therapy within 4 weeks or 5 times of t1/2. 14.Has = grade 2 toxicity caused by previous anti-tumor treatment. 15. HBsAg positive and HBV DNA positive (=ULN);HCV antibody and HCV-RNA positive (=ULN); HIV positive or =HIV ULN.

16. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.

18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

Drug:
• TQB3804
A kind of tyrosine kinase inhibitor.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

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	Dose-limiting toxicity (DLT)	Subjects appear the following toxic reaction relate to the drug after treatment within 28 days :III °or above of non-hematological toxicity, IV° hematological toxicity , neutropenia associated with fever.	Baseline up to 28 days
Secondary	Cmax	Cmax is the maximum plasma concentration of TQB3804 or metabolite(s).	Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.
Secondary	Tmax	To characterize the pharmacokinetics of TQB3804 by assessment of time to reach maximum plasma concentration.	Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.
Secondary	AUC0-t	To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.	Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.
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.	Baseline up to 52 weeks
Secondary	Objective Response Rate(ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	Baseline up to 52 weeks
Secondary	Disease Control Rate(DCR)	Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).	Baseline up to 52 weeks