A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors

TT00434CN01

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

2021-07-12

2023-10-18

2023-10-18

Completed

Early phase I

11

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-11-21