Clinical trial NCT04523285: A Phase I Study of TQB728 Tablets on Tolerance and Pharmacokinetics
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, and Pharmacokinetics of TQB3728 Tablets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor or Hematologic Tumor
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-21
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 open-label, phase I study to evaluate tolerance and pharmacokinetics of TQB3728 tablets in subjects with advanced solid tumor or hematologic tumor.


Eligibility criteria: Inclusion Criteria:

* 1.Understood and signed an informed consent form. 2.Histologically or cytologically confirmed advanced/metastatic or refractory solid tumor or lymphoma. No approved standard treatment regimen or ineffective or intolerant to standard treatment regimen.

  3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.

  4. Has at least one measurable lesion (solid tumors based on RECIST V1.1, lymphoma based on Lugano 2014).

  5.Adequate organ system function. 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 first administration.

Exclusion Criteria:

* 1.Hypersensitivity to TQB3728 or its excipient. 2.Has received chemotherapy, radiotherapy, hormone therapy, immunotherapy, targeted therapy, biotherapy or any other antitumor therapy within 4 weeks before first administration.

  3.Has received allogeneic hematopoietic stem cell transplantation or organ transplantation, or received autologous hematopoietic stem cell transplantation within 12 weeks before administration.

  4.Has multiple factors affecting oral medication. 5.Has primary CNS lymphoma or CNS metastasis with untreated or uncontrolled symptoms.

  6.Pregnant or lactating women. 7.Has severe or uncontrolled systemic disease. 8.Has serious cardiovascular diseases. 9.Has neurological or mental disorders. 10.Has autoimmune disease or diseases requiring systemic hormones or immunosuppressive drugs.

  11.Has active viral infection. 12.The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 1, except for hair loss.

  13. Has received major surgery within 4 weeks before the first administration. 14.Has participated in other clinical trials within 4 weeks before participating in this trial.

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

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Tmax
timeFrame: 30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
measure: Cmax
timeFrame: 30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
measure: AUC0-t
timeFrame: 30minutes pre-dose on day 1and day 8; 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
measure: Progression-free survival (PFS)
timeFrame: up to 48 weeks
measure: Overall response rate (ORR)
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: