A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I, Open-label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144855
• Other study ID #: TQB3474-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yongsheng Wang, Doctor
• Phone: 028-85422707
• Email: licdzk[@]163.com
• 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 TQB3474 in patients with advanced malignant tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2021
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1.18 and 70 years old.

2. Histologically or cytologically confirmed advanced solid tumors.

3. Has the surgery more than 4 weeks before the first dose.

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

5. Life expectancy =12 weeks.

6. Adequate organ system function.

7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study.

8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Has received chemotherapy or radiotherapy within 4 weeks before the first dose.

2. Hypersensitivity to TQB3474 or its excipient.

3. Has factors that impact on intravenous infusion of drugs and venous blood collection.

4. Has severe gastrointestinal disease within 4 weeks before the first dose.

5. Has severe eye disease.

6. Breastfeeding or pregnant women.

7. Has brain metastases.

8. HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNA positive (=1000 copies /mL).

9. Has infection that need systemic treatment during screening.

10. Has participated in any other clinical trial within 4 weeks before the first dose.

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 Tumor

Intervention

Drug:
• TQB3474 injection
This is a kind of heat shock protein (HSP90) inhibitor.

Locations

Country	Name	City	State
China	Yongsheng	Chendu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Guizhou Cancer Hospital	Guiyang	Guizhou

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 , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding.	Baseline up to 28 days
Secondary	Cmax	Cmax is the maximum plasma concentration of TQB3474 or metabolite(s).	0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.
Secondary	Tmax	To characterize the pharmacokinetics of TQB3474 by assessment of time to reach maximum plasma concentration.	0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.
Secondary	AUC0-t	To characterize the pharmacokinetics of TQB3474 by assessment of area under the plasma concentration time curve from zero to infinity.	0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29.