Clinical trial · Interventional
Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors
A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors
NCT04830501CI-TRIAL-00071529completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TT-00434 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- This study adopts an accelerated titration design (ATD) and utilizes an accelerated dose escalation phase in order to minimize suboptimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD.
- interventionNames
- Drug: TT-00434
Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- At the end of Cycle 1 (each cycle is 28 days)
- description
- Safety and tolerability
- measure
- Incidence of AEs
- timeFrame
- up to 30 days from study discontinuation
- description
- Safety and tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.