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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TransThera Biosciences Co., Ltd; TransThera Sciences (Nanjing), Inc.

Criteria

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.