A Study of TQB3455 Tablets in Subjects With Advanced Malignancies

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    50
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 24 January 2021
measurable disease
idh2 gene mutation

Summary

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

Details
Condition Advanced Malignancies
Treatment TQB3455
Clinical Study IdentifierNCT04340427
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. 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

Relapsed after bone marrow transplantation. 2.Has received systemic antitumor therapy or radiation therapy within 3 weeks before the first dose
Has participated in other clinical trial within four weeks before the first
dose
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
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
Has central nervous system leukemia
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note