A Study of TQB3455 Tablets in Subjects With Advanced Malignancies

CTTQ

Status and phase: Unknown; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: TQB3455

Study type: Interventional

Funder types: Industry

Identifiers

NCT04340427

TQB3455-I-02

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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

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

  5. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

TQB3455 Tablets

Experimental group

Description:

TQB3455 Tablet administered orally once. Then TQB3455 Tablet administered orally, once daily in 28-day cycle after 7 days of first administration.

Treatment:

Drug: TQB3455