Clinical trial NCT04144855: A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection
Official title: A Phase I, Open-label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Cmax
timeFrame: 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.
measure: Tmax
timeFrame: 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.
measure: AUC0-t
timeFrame: 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.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Chendu
country: China
facility: Yongsheng
state: Sichuan
Study officials:
References: