^
    4ms
    Study of TT-00420 (Tinengotinib) in Subjects With Cholangiocarcinoma Who Failed or Relapsed to Chemotherapy and FGFR Inhibitor (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, TransThera Sciences (Nanjing), Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    tinengotinib (TT-00420)
    4ms
    Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=48, Completed, TransThera Sciences (Nanjing), Inc. | Active, not recruiting --> Completed
    Trial completion
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    tinengotinib (TT-00420)
    5ms
    A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Akeso
    New P2 trial
    |
    tinengotinib (TT-00420) • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    6ms
    To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=84, Completed, TransThera Sciences (Nanjing), Inc. | Recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024
    Trial completion • Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Tecentriq (atezolizumab) • albumin-bound paclitaxel • tinengotinib (TT-00420)
    11ms
    Multiple Kinase Small Molecule Inhibitor Tinengotinib (TT-00420) Alone or With Chemotherapy Inhibit the Growth of SCLC. (PubMed, Cancer Sci)
    When combined with etoposide/cisplatin, it synergistically inhibited SCLC growth. Mechanistic studies revealed that c-Myc expression may be a key factor influencing the effect of tinengotinib in SCLC-N. This study provides reliable preclinical data and a new direction for tinengotinib as a promising therapy for SCLC, either alone or in combination with chemotherapy.
    Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • NEUROD1 (Neuronal Differentiation 1)
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    MYC expression
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    cisplatin • etoposide IV • tinengotinib (TT-00420)
    12ms
    A Model for Decoding Resistance in Precision Oncology: Acquired Resistance to FGFR inhibitors in Cholangiocarcinoma. (PubMed, Ann Oncol)
    Our multimodal analysis led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. FGFR inhibitors should be small, high-affinity, and selective for specific FGFR family members. Tinengotinib, a novel small molecule inhibitor with these characteristics, exhibited preclinical and clinical activity against key resistance mutations. This integrated approach offers a blueprint for advancing drug resistance research across cancer types.
    Preclinical • Journal
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    FGFR2 (Fibroblast growth factor receptor 2)
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    FGFR2 mutation
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    tinengotinib (TT-00420)
    over1year
    A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer (clinicaltrials.gov)
    P1/2, N=50, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial • Combination therapy • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • prednisone • tinengotinib (TT-00420)
    over1year
    Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=203, Completed, TransThera Sciences (Nanjing), Inc. | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
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    FGFR (Fibroblast Growth Factor Receptor)
    |
    albumin-bound paclitaxel • tinengotinib (TT-00420)
    over1year
    Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=55, Completed, TransThera Sciences (Nanjing), Inc. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR1 mutation • FGFR1 fusion • FGFR wild-type
    |
    tinengotinib (TT-00420)
    over1year
    Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P=N/A, N=0, Available, TransThera Sciences (Nanjing), Inc.
    New trial • Metastases
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    tinengotinib (TT-00420)
    almost2years
    First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors. (PubMed, Oncologist)
    Tinengotinib was well tolerated with favorable pharmacokinetic characteristics. Preliminary findings indicated potential clinical benefit in FGFR inhibitor-refractory cholangiocarcinoma, HER2-negative breast cancer (including TNBC), and CRPC. Continued evaluation of tinengotinib is warranted in phase II trials.
    P1 data • Journal • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2) • JAK1 (Janus Kinase 1)
    |
    HER-2 positive • HR positive • HER-2 negative • FGFR2 mutation • FGFR2 fusion • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    tinengotinib (TT-00420)
    almost2years
    Safety and Efficacy of TT-00420 Tablets Combined With Toripalimab Injection in Advanced Urological Tumors (clinicaltrials.gov)
    P1/2, N=42, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P1/2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • tinengotinib (TT-00420)