A Phase I Study of TQB728 Tablets on Tolerance and Pharmacokinetics

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumor or Hematologic Tumor

Treatments

Drug: TQB3728

Study type

Interventional

Funder types

Industry

Identifiers

NCT04523285

TQB3728-I-01

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.
1. 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.
1. 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.