Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Tvardi Therapeutics, Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the maximum tolerated dose (MTD), dose-limiting toxicities, and tolerability of TTI-101 administered orally to patients with advanced breast cancer and other solid tumors. Dose-limiting toxicity is defined as a Grade 3 or above adverse event (using CTCAE v5.0) within the first treatment cycle (28-days).
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 |
What the finished NCT03195699 record still lists
NCT03195699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT03195699's enrollment target sits among peer trials
64 725th of 1224 higher than 499 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI