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NCT03195699 · ClinicalTrials.gov registry record · Phase 1
Oral STAT3 Inhibitor, TTI-101, in Patients with Advanced Cancers
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Tvardi Therapeutics, Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 2
- Study locations
NCT03195699 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that has completed, run by Tvardi Therapeutics, Incorporated. The registered enrollment target is 64 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03195699, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, has completed, sponsored by Tvardi Therapeutics, Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 2
- Study locations
Study Summary
Many patients have cancers that have increased activity of a protein called STAT3 that contributes critically to the development and growth of their cancer. Despite our knowledge of STAT3's importance to cancer, scientists and doctors have not developed a drug that targets it and that patients can take to treat their cancer more effectively than treatments that are now available. Tvardi Therapeutics, Incorporated has developed a compound, TTI-101, which can be given by mouth and acts as a direct inhibitor of STAT3. Administration of TTI-101 to mice demonstrated that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was safe when administered at high doses to mice, rats, and dogs. In this application, Tvardi is proposing to further develop TTI-101 for treatment of solid tumors for which the prognosis is dismal. The investigators will determine how safe it is when administered to patients with cancer, determine whether an adequate dose can be administered to patients with cancer that will block STAT3 in their cancer, and determine whether treatment with TTI-101 leads to reduced growth of their cancer.
Conditions Studied
Interventions
- DRUG TTI-101
Study Locations (2)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- Mays Cancer Center at University of Texas Health Science Center SA - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03195699
The ClinicalTrials.gov registry entry for NCT03195699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Tvardi Therapeutics, Incorporated, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which TTI-101 is the first listed.
NCT03195699 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03195699 about?
NCT03195699 is a clinical study titled "Oral STAT3 Inhibitor, TTI-101, in Patients with Advanced Cancers". Many patients have cancers that have increased activity of a protein called STAT3 that contributes critically to the development and growth of their cancer. Despite our knowledge of STAT3's importance to cancer, scientists and doctors have not developed a drug that targets it and that patients can t...
What is the current status of trial NCT03195699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2017-11-15. Estimated completion is 2024-06-24.
What conditions does trial NCT03195699 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Melanoma, Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT03195699?
The interventions under investigation include: TTI-101 (DRUG).
Who is sponsoring clinical trial NCT03195699?
This trial is sponsored by Tvardi Therapeutics, Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03195699 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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