A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumor or Hematologic Tumor

Treatments

Drug: TQB3454

Study type

Interventional

Funder types

Industry

Identifiers

NCT04481607

TQB3454-I-02

Details and patient eligibility

About

This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.

Exclusion criteria

1. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
2. Has received IDH1 mutation inhibitor.
3. Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
4. Has received oral targeted drugs, less than 5 drug half-lives from first dose.
5. The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
  
  3.Complicated disease and medical history:

1. Active hepatitis B or hepatitis C.
2. Abnormal kidney.
3. Abnormal cardiovascular and cerebrovascular.
4. Abnormal gastrointestinal.
5. Has medical history of immunodeficiency.
6. Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
7. Has uncontrollable systemic bacterial, fungal or viral active infections.
8. Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
9. Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
10. Has neurological or mental disorders.
11. Has a history of drug abuse or drug addict.
12. Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
  1. Has participated in other clinical trials within 30 days before participating in this trial.
  2. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
  3. criteria for solid tumors:

1. Has any signs of bleeding constitution.
2. Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
3. Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
4. Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
5. Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.