Clinical trial NCT04340427: A Study of TQB3455 Tablets in Subjects With Advanced Malignancies
Official title: A Phase I Study of TQB3455 Tablets in Subjects With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
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, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3455 tablets in subjects with advanced malignancies.


Eligibility criteria: Inclusion Criteria:

* 1. ≥ 18 years old； Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.

  2. Has IDH2 gene mutation will be selected preferentially. 3. The toxicity of radiotherapy or other antitumor therapy should return to grade 1.

  4. No pregnant or lactating women, all the participants should use contraceptives.

  5. Understood and signed an informed consent form. 6. Advanced/metastatic solid tumors or refractory/recurrent acute myeloid leukemia.

  7. At least one measurable lesion for solid tumors. 8. Adequate organ system function.

Exclusion Criteria:

* 1.Relapsed after bone marrow transplantation. 2.Has received systemic antitumor therapy or radiation therapy within 3 weeks before the first dose.

  3.Has participated in other clinical trial within four weeks before the first dose.

  4.Has multiple factors affecting oral medication. 5.Has uncontrolled, active systemic fungal, bacterial, or viral infections. 6.Poorly controlled hypertension. 7.Has serious cardiovascular disease. 8.Has drug abuse history that unable to abstain from or mental disorders. 9.Has active hepatitis B or C. 10.Have a history of immunodeficiency. 11.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

  12.Has central nervous system metastasis with the exception of glioma subjects. 13.Has severe life-threatening complication of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.

  14.Has central nervous system leukemia.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Cmax
timeFrame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.
measure: Tmax
timeFrame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.
measure: AUC0-t
timeFrame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.
measure: α-Hydroxyglutaric acid (2-HG)
timeFrame: Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 and cycle 3; Day 1 pre-dose on multiple dose from cycle 4 to cycle 8. Each cycle is 28 days.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
Study officials:
References: