A Study of TQB3455 Tablets in Subjects With Advanced Malignancies

NCT ID: NCT04340427

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2021-12-31

Brief Summary

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

Conditions

Advanced Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3455 Tablets

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

Group Type: EXPERIMENTAL

TQB3455

Intervention Type: DRUG

TQB3455 tablets is a small molecule oral drug inhibiting IDH2 mutation.

Interventions

TQB3455

TQB3455 tablets is a small molecule oral drug inhibiting IDH2 mutation.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weiqi Nian

Role: CONTACT

nwqone@126.com

023-65079277

Facility Contacts

Weiqi Nian, M.D.

Role: primary

nwqone@126.com

023-65079277

Other Identifiers

TQB3455-I-02

Identifier Type: -

Identifier Source: org_study_id