Clinical trial NCT04275583: A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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.Understood and signed an informed consent form. 2.18 and 75 years old , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

  4. Life expectancy ≥12 weeks. 5. Relapsed/refractory multiple myeloma had received at least two treatment methods.

  6. 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 (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion Criteria:

* 1. Hypersensitivity to TQB3602 or its excipient. 2. Has peripheral nerve diseases ≥ grade 2. 3. Has diarrhea grade \> 1 during screening period. 4. Has received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic antitumor therapies within 14 days before the first dose.

  5. Has received ixazomib and less than 5 half-life before the first dose. 6. Has received allogeneic stem cell transplant. 7. Pregnant or lactating women. 8. Has participated in other clinical trials within 4 weeks before participating in this trial.

  9. 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, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
measure: Tmax
timeFrame: 0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
measure: AUC0-t
timeFrame: 0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China hospital, Sichuan University
state: Sichuan
Study officials:
References: