A Phase I Study of TQB728 Tablets on Tolerance and Pharmacokinetics

NCT ID: NCT04523285

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-05-30

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.

Conditions

Advanced Solid Tumor or Hematologic Tumor

Study Design

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

Study Groups

TQB3728 tablets

TQB3728 tablets administered orally, once a week in 28-day cycle.

Group Type: EXPERIMENTAL

TQB3728

Intervention Type: DRUG

TQB3728 tablets is a small molecule oral drug.

Interventions

TQB3728

TQB3728 tablets is a small molecule oral drug.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shusen Wang, Doctor

Role: CONTACT

Phone: 020-87342693

Email: wangshs@sysucc.org.cn

Facility Contacts

Shusen Wang, Doctor

Role: primary

Other Identifiers

TQB3728-I-01

Identifier Type: -

Identifier Source: org_study_id