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Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer
NCT03654547 · View on ClinicalTrials.gov ↗
Study Summary
This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.
Conditions Studied
Interventions
- DRUG TT-00420
Study Locations (2)
Texas
- MD Anderson Cancer Center — Houston
Beijing Municipality
- Cancer Hopital Chinese Academy of Medical Sciences — Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03654547
The ClinicalTrials.gov registry entry for NCT03654547 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TransThera Sciences (Nanjing), which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which TT-00420 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03654547 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Texas, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03654547 about?
NCT03654547 is a clinical study titled "Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer". This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study co...
What is the current status of trial NCT03654547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-01-08. Estimated completion is 2024-02-28.
What conditions does trial NCT03654547 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03654547?
The interventions under investigation include: TT-00420 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03654547?
This trial is sponsored by TransThera Sciences (Nanjing), which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03654547 being conducted?
This trial has 2 study locations across Texas, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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