Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04481607
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor or Hematologic Tumor Drug: TQB3454 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: TQB3454 tablets
TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration.
Drug: TQB3454
TQB3454 tablets is a small molecule oral drug.




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: Baseline up to 28 days ]
    MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]
    Cmax is the maximum plasma concentration of TQB3454 or metabolite(s).

  2. Tmax [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]
    To characterize the pharmacokinetics of TQB3454 by assessment of time to reach maximum plasma concentration.

  3. AUC0-t [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]
    To characterize the pharmacokinetics of TQB3454 by assessment of area under the plasma concentration time curve from zero to infinity.

  4. Objective response rate (ORR) [ Time Frame: up to 60 weeks ]
    Percentage of participants achieving complete response (CR) and partial response (PR).

  5. Progression-free survival (PFS) [ Time Frame: Up to 60 weeks ]
    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

  6. 2-hydroxyglutaric acid [ Time Frame: Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days. ]
    Correlation between 2-hydroxyglutaric acid and efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

2. 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:

    1. Has received IDH1 mutation inhibitor.
    2. Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
    3. Has received oral targeted drugs, less than 5 drug half-lives from first dose.
    4. 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.

      4. Has participated in other clinical trials within 30 days before participating in this trial.

      5. 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.

      7. 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.

criteria for blood tumor:

a) Has severe life-threatening leukemia complications.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481607


Contacts
Layout table for location contacts
Contact: Lin Shen, Doctor 010-88196340 doctorshenlin@sina.cn

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100089
Contact: Lin Shen, Doctor    010-88196340    doctorshenlin@sina.cn   
Principal Investigator: Lin Shen, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Layout table for additonal information
Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04481607    
Other Study ID Numbers: TQB3454-I-02
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No