NCT03195699

Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

Completed Phase 1 Last updated 21 March 2025

What this trial tests

Phase 1 trial testing TTI-101 in Breast Cancer in 64 participants. Completed in 24 June 2024.

Timeline

15 November 2017

Primary endpoint
24 June 2024

24 June 2024

Quick facts

Lead sponsor	Tvardi Therapeutics, Incorporated
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	15 November 2017
Primary completion	24 June 2024
Estimated completion	24 June 2024
Sites	2 locations across United States

Drugs / interventions tested

• TTI-101 — full drug profile →
• TTI-101 — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Hepatocellular Cancer — all drugs for Hepatocellular Cancer →

Sponsor

Tvardi Therapeutics, Incorporated — full company profile →

Who can join

Adults 18 to 65, any sex, with Breast Cancer or Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the IL-6/JAK/STAT3 signalling axis in cancer.
   Johnson DE, O'Keefe RA, Grandis JR. · · 2018 · cited 2398× · PMID 29405201 · DOI 10.1038/nrclinonc.2018.8
2. Comprehensive review of targeted therapy for colorectal cancer.
   Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
3. Targeting STAT3 in Cancer Immunotherapy.
   Zou S, Tong Q, Liu B, Huang W, et al · · 2020 · cited 787× · PMID 32972405 · DOI 10.1186/s12943-020-01258-7
4. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
5. Mechanisms of Chemotherapy Resistance in Triple-Negative Breast Cancer-How We Can Rise to the Challenge.
   Nedeljković M, Damjanović A. · · 2019 · cited 576× · PMID 31443516 · DOI 10.3390/cells8090957
6. Evolving cognition of the JAK-STAT signaling pathway: autoimmune disorders and cancer.
   Xue C, Yao Q, Gu X, Shi Q, et al · · 2023 · cited 399× · PMID 37208335 · DOI 10.1038/s41392-023-01468-7
7. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
8. STAT3 as a potential therapeutic target in triple negative breast cancer: a systematic review.
   Qin JJ, Yan L, Zhang J, Zhang WD. · · 2019 · cited 278× · PMID 31088482 · DOI 10.1186/s13046-019-1206-z