A Study of TQB3455 Tablets in Subjects With Advanced Malignancies

  • days left to enroll
  • participants needed
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 24 January 2021
measurable disease
idh2 gene mutation


This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3455 tablets in subjects with advanced malignancies.

Condition Advanced Malignancies
Treatment TQB3455
Clinical Study IdentifierNCT04340427
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

\. 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

Relapsed after bone marrow transplantation. 2.Has received systemic antitumor therapy or radiation therapy within 3 weeks before the first dose
Has participated in other clinical trial within four weeks before the first
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
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
Has central nervous system leukemia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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