Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    20
  • sponsor
    TransThera Sciences (Nanjing), Inc.
Updated on 2 November 2021

Summary

This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.

Description

This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations.

Details
Condition Advanced Solid Tumors
Treatment TT-00434
Clinical Study IdentifierNCT04830501
SponsorTransThera Sciences (Nanjing), Inc.
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 20 years
Patients must have a histological or cytologically confirmed diagnosis of advanced or recurrent malignant solid tumors
Patients have received all currently available standard treatments (unless the therapy is contraindicated, intolerable or unavailable due to any reasons)
Patients must have measurable or evaluable disease (according to RECIST 1.1)
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment
Patients must have fully understood and voluntarily signed informed consent form (ICF) for this study

Exclusion Criteria

Patients who received other investigational products or devices in other clinical trials within 4 weeks before the first dose
Patients who received anti-tumor therapy within 4 weeks, or within 5-half-lives (which is longer) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enrol), targeted therapy or immunotherapy
Patients who have previous toxicity of anti-tumor therapy that has not recovered to Grade 1. (except for Grade 2 alopecia, chemotherapy-induced peripheral neurotoxicity, and ototoxicity)
Patients who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of TT-00434 will be interfered
Patients underwent major surgery (except biopsy) within 4 weeks, or the surgical incision has not completely healed prior to the first dose
Patients who have active bacterial or fungal infections (CTCAE, Grade 2) that required systemic treatment within 2 weeks prior to the first dose
Patients who have active HBV infection (HBV DNA copies ULN) and/or HCV infection (HCV RNA copies ULN)
Patients who test positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
Has received a live-virus vaccination within 30 days of planned first dose NOTE: Seasonal flu vaccines are permitted
Known or suspected drug hypersensitivity to any ingredients of TT-00434 tablets
Female patients in pregnancy or lactation. Male patients or female patients at reproductive ages who are unwilling to receive effective contraceptive measures
Patients who are judged by the Investigator to be unsuitable for this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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