A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: TQB3474 injection

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yongsheng Wang, Doctor; Phone Number: 028-85422707; Email: licdzk@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Not yet recruiting
      • Chongqing Cancer Hospital
      • Contact: Weiqi Nian, Doctor; Phone Number: 023-65079277; Email: nwqone@126.com
      • Principal Investigator: Weiqi Nian, Doctor
  • Guizhou
    • Guiyang, Guizhou, China, 550008
      • Not yet recruiting
      • Guizhou Cancer Hospital
      • Contact: Weiwei Ouyang, Doctor; Phone Number: 0851-86523929; Email: Ouyangww103173@163.com
      • Principal Investigator: Weiwei Ouyang
  • Sichuan
    • Chendu, Sichuan, China, 610000
      • Recruiting
      • Yongsheng
      • Contact: Yongsheng Wang, Doctor; Phone Number: 028-85422707; Email: licdzk@163.com
      • Principal Investigator: Yongsheng Wang, Doctor
      • Principal Investigator: Li Zheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TQB3474 injection; Participants receive TQB3474 injection by intravenous (IV) infusion on Day 1, 8, 15, 22 of each 28 day cycle.	Drug: TQB3474 injection; This is a kind of heat shock protein (HSP90) inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2018
• Primary Completion (ANTICIPATED): November 27, 2020
• Study Completion (ANTICIPATED): May 30, 2021

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TQB3474-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No