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NCT03654547 · ClinicalTrials.gov registry record · Phase 1
Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer
A Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer, sponsored by TransThera Sciences (Nanjing).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT03654547: Completed Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer, sponsored by TransThera Sciences (Nanjing).
NCT03654547 is a Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer that has completed, run by TransThera Sciences (Nanjing). The registered enrollment target is 48 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654547, a Phase 1 study of Advanced Solid Tumors and Triple Negative Breast Cancer, has completed, sponsored by TransThera Sciences (Nanjing).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
FIH Dose Finding
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 |
What the finished NCT03654547 record still lists
NCT03654547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower).
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.
NCT03654547 reports a single indexed study location in Texas, Beijing Municipality.
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.
What interventions are being tested in trial NCT03654547?
The interventions under investigation include: TT-00420 (DRUG).
Who is sponsoring clinical trial NCT03654547?
This trial is sponsored by TransThera Sciences (Nanjing), which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03654547's enrollment target sits among peer trials
48 103rd of 144 higher than 41 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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