^
    18d
    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 (clinicaltrials.gov)
    P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=33 --> 0 | Trial completion date: Jun 2028 --> Nov 2025 | Active, not recruiting --> Withdrawn | Trial primary completion date: Jun 2026 --> Nov 2025
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    TTI-101 oral
    21d
    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 (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    TTI-101 oral
    2ms
    Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov)
    P2, N=100, Completed, Tvardi Therapeutics, Incorporated | Active, not recruiting --> Completed | N=75 --> 100
    Trial completion • Enrollment change
    |
    TTI-101 oral
    5ms
    Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=18, Recruiting, University of Colorado, Denver | Suspended --> Recruiting
    Enrollment open
    |
    TTI-101 oral
    6ms
    ROS-Responsive Hydrogel for Localized Delivery of Nampt and Stat3 Inhibitors Exhibits Synergistic Antitumor Effects in Colorectal Cancer Through Ferroptosis Induction and Immune Microenvironment Remodeling. (PubMed, Adv Sci (Weinh))
    Intriguingly, mass cytometry time-of-flight (CyTOF) analysis indicates that the combined treatment with FK866 and C188-9 exerts antitumor effects by increasing the infiltration of CD8+ T cells and neutrophils into the tumor, as well as enhancing the expression of immune-regulatory molecules, including IFN-γ, IL-10, and perforin. Thus, this localized treatment not only minimizes systemic adverse effects, but also markedly amplifies antitumor efficacy through the modulation of both tumor cells and the tumor immune microenvironment, representing a promising antitumor treatment strategy.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL10 (Interleukin 10) • GPX4 (Glutathione Peroxidase 4) • NAMPT (Nicotinamide Phosphoribosyltransferase)
    |
    daporinad (APO866) • TTI-101 oral
    6ms
    Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=18, Suspended, University of Colorado, Denver | N=35 --> 18
    Enrollment change
    |
    TTI-101 oral
    7ms
    Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov)
    P2, N=75, Active, not recruiting, Tvardi Therapeutics, Incorporated | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    TTI-101 oral
    7ms
    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 (clinicaltrials.gov)
    P1, N=33, Not yet recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Jun 2028 | Trial primary completion date: Feb 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    TTI-101 oral
    9ms
    A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=178, Recruiting, Tvardi Therapeutics, Incorporated | Trial completion date: Mar 2025 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • TTI-101 oral
    9ms
    Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov)
    P2, N=75, Recruiting, Tvardi Therapeutics, Incorporated | Trial primary completion date: Mar 2025 --> Jul 2025
    Trial primary completion date
    |
    TTI-101 oral
    9ms
    Oral STAT3 Inhibitor, TTI-101, in Patients with Advanced Cancers (clinicaltrials.gov)
    P1, N=64, Completed, Tvardi Therapeutics, Incorporated | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Dec 2024 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    TTI-101 oral
    10ms
    REVERT: Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=6, Terminated, Tvardi Therapeutics, Incorporated | Phase classification: P1/2 --> P1 | Completed --> Terminated; The study was terminated prior to Phase 2 due to slow accrual.
    Phase classification • Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • TTI-101 oral