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    DRUG CLASS:

    5T4 inhibitor

    Related drugs:
    1m
    A study to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21 oncolytic vaccinia virus injection (hV01) and ready-to-use CAR-raNK cells (IBR854) in patients with advanced malignant solid tumors (ChiCTR2500109506)
    P=N/A, N=5, Completed, Xiamen Humanity Hospital; Xiamen Humanity Hospital
    New trial
    |
    IBR854 • hV01
    4ms
    A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Imbioray (Hangzhou) Biomedicine Co., Ltd.
    New P2 trial
    |
    pazopanib • IBR854
    5ms
    Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16 (clinicaltrials.gov)
    P1, N=68, Recruiting, Sound Biopharmaceuticals Ltd. | Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> Nov 2027 | Trial primary completion date: Jan 2026 --> Nov 2026
    Enrollment open • Trial completion date • Trial primary completion date
    6ms
    A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1, N=70, Recruiting, Chiome Bioscience Inc.
    New P1 trial
    |
    Keytruda (pembrolizumab) • CBA-1535
    almost2years
    Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Imbioray (Hangzhou) Biomedicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    IBR854
    over2years
    ALG.APV-527 First-in-human Study (clinicaltrials.gov)
    P1/2, N=56, Recruiting, Aptevo Therapeutics
    New P1/2 trial • Metastases
    |
    ALG.APV-527
    over2years
    Preclinical characterization of CBA-1535, a novel bi-specific tribody, with two binding sites to 5T4 and one site to CD3ε (AACR 2023)
    These results provide the strong rationale for further clinical evaluation ofCBA-1535 in 5T4 positive tumors. CBA-1535 is now under the phase 1 trial in Japan (jRCT2031210708), with 2 parts, the monotherapy and the combination with Pembrolizumab.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2RA (Interleukin 2 receptor, alpha) • TPBG (Trophoblast Glycoprotein) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • AIF1 (Allograft Inflammatory Factor 1)
    |
    TPBG expression • TPBG positive
    |
    Keytruda (pembrolizumab) • CBA-1535
    3years
    Mechanistic and pharmacodynamic studies of DuoBody-CD3x5T4 in preclinical tumor models. (PubMed, Life Sci Alliance)
    Lastly, in dissociated patient-derived tumor samples, DuoBody-CD3x5T4 activated tumor-infiltrating lymphocytes and induced tumor-cell cytotoxicity, even when most tumor-infiltrating lymphocytes expressed PD-1. These data provide an in-depth view on the mechanism of action of a CD3 bsAb in preclinical models of solid cancer.
    PK/PD data • Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • GZMB (Granzyme B) • IFNGR1 (Interferon Gamma Receptor 1)
    |
    PD-1 expression
    |
    GEN1044
    3years
    Study of Anti-5T4 CAR-raNK Cell Therapy in Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=56, Recruiting, Shanghai East Hospital | Trial completion date: Aug 2022 --> May 2023 | Trial primary completion date: Aug 2022 --> Apr 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1) • IL10 (Interleukin 10)
    |
    EGFR mutation
    |
    IBR854
    over3years
    Study of Anti-5T4 CAR-raNK Cell Therapy in Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=56, Recruiting, Shanghai East Hospital | N=136 --> 56
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1) • IL10 (Interleukin 10)
    |
    EGFR mutation
    |
    IBR854
    over3years
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=50, Recruiting, NeoTX Therapeutics Ltd. | Trial completion date: Jul 2022 --> Mar 2023 | Trial primary completion date: Apr 2022 --> Dec 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TPBG (Trophoblast Glycoprotein)
    |
    HER-2 negative • TPBG positive
    |
    Imfinzi (durvalumab) • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)