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A Study of TQB3455 Tablets in Subjects With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT04340427
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: TQB3455 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of TQB3455 Tablets in Subjects With Advanced Malignancies
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: TQB3455 Tablets
TQB3455 Tablet administered orally once. Then TQB3455 Tablet administered orally, once daily in 28-day cycle after 7 days of first administration.
 Drug: TQB3455
TQB3455 tablets is a small molecule oral drug inhibiting IDH2 mutation.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: Baseline up to 28 days ]
    Subjects appear the toxic reaction relate to the drug after treatment within 28 days.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28. ]
    Cmax is the maximum plasma concentration of TQB3455 or metabolite(s).

  2. Tmax [ Time Frame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28. ]
    To characterize the pharmacokinetics of TQB3455 by assessment of time to reach maximum plasma concentration.

  3. AUC0-t [ Time Frame: Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28. ]
    To characterize the pharmacokinetics of TQB3455 by assessment of area under the plasma concentration time curve from zero to infinity.

  4. α-Hydroxyglutaric acid (2-HG) [ Time Frame: Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 and cycle 3; Day 1 pre-dose on multiple dose from cycle 4 to cycle 8. Each cycle is 28 days. ]
    The concentration of 2-HG.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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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): NCT04340427


Contacts
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Contact: Weiqi Nian 023-65079277 nwqone@126.com

Locations
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China, Chongqing
Chongqing University Cancer Hospital Recruiting
Chongqing, Chongqing, China
Contact: Weiqi Nian, M.D.    023-65079277    nwqone@126.com   
Principal Investigator: Weiqi Nian, M.D.         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04340427    
Other Study ID Numbers: TQB3455-I-02
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms