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TTI-101

DRUG7 trials

Sponsors

Tvardi Therapeutics, Incorporated, M.D. Anderson Cancer Center, Washington University School of Medicine

Conditions

Advanced CancerBreast CancerColorectal CancerGastric AdenocarcinomaHead and Neck Squamous Cell CarcinomaHepatocellular CancerHepatocellular CarcinomaIdiopathic Pulmonary Fibrosis

Early Phase 1

Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck
WithdrawnNCT05845307
M.D. Anderson Cancer CenterSquamous Cell Carcinoma of Head and Neck
Start: 2025-06-20End: 2025-11-13Updated: 2025-12-08

Phase 1

Oral STAT3 Inhibitor, TTI-101, in Patients with Advanced Cancers
CompletedNCT03195699
Tvardi Therapeutics, IncorporatedAdvanced Cancer, Breast Cancer, Colorectal Cancer +5
Start: 2017-11-15End: 2024-06-24Updated: 2025-03-21
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
TerminatedNCT05384119
Tvardi Therapeutics, IncorporatedBreast Cancer
Start: 2023-01-09End: 2024-04-25Updated: 2025-02-21
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
RecruitingNCT05440708
Tvardi Therapeutics, IncorporatedHepatocellular Carcinoma
Start: 2023-03-23End: 2027-03-10Target: 193Updated: 2026-04-27
Phase I/II Open Label Study Evaluating the Safety and Efficacy of Combining STAT3 Inhibition (TTI-101) With Anti-PD-1 Therapy (Pembrolizumab) in Patients With Recurrent or Metastatic (RM) Head and Neck Squamous Cell Carcinoma (HNSCC)
WithdrawnNCT05668949
M.D. Anderson Cancer CenterHead and Neck Squamous Cell Carcinoma
Start: 2025-09-23End: 2025-09-23Updated: 2025-12-17
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Active, not recruitingNCT06141031
Washington University School of MedicinePancreatic Cancer
Start: 2024-01-16End: 2029-06-30Updated: 2026-05-12

Phase 2

Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
CompletedNCT05671835
Tvardi Therapeutics, IncorporatedIdiopathic Pulmonary Fibrosis
Start: 2023-05-15End: 2025-08-14Updated: 2025-09-30

Related Papers

Phase I Trial of TTI-101, a First-in-Class Oral Inhibitor of STAT3, in Patients with Advanced Solid Tumors
Clinical Cancer Research2025-01-1024 citations
STAT3-VDAC1 Axis Modulates Mitochondrial Function and Plays a Critical Role in the Survival of Leukemic Stem Cells
Blood2024-11-05
A phase 1b/2 study to evaluate the safety and efficacy of TTI-101 as monotherapy and in combination in advanced hepatocellular carcinoma.
Journal of Clinical Oncology2024-01-201 citations
Phase 1 trial evaluating TTI-101, a first-in-class, orally bioavailable, small molecule, inhibitor of STAT3, in patients with advanced solid tumors.
Journal of Clinical Oncology2023-06-0114 citations
First-in-man phase I clinical trial evaluating TTI-101, an orally bioavailable, small molecule inhibitor of STAT3, in patients with advanced solid tumors.
Journal of Clinical Oncology2021-05-208 citations