Status:
COMPLETED
Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors
Lead Sponsor:
TransThera Sciences (Nanjing), Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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.
Detailed 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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04830501
Start Date
July 12 2021
End Date
October 18 2023
Last Update
November 21 2023
Active Locations (3)
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1
National Cheng Kung University Hospital
Tainan, Taiwan
2
Taipei Medical University Hospital
Taipei, Taiwan
3
Tri-Service General Hospital
Taipei, Taiwan