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    DRUG CLASS:

    TCR modulator

    Related drugs:
    14d
    IMA402-101: IMA402 T Cell-Engaging Receptor Molecule (TCER) in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Immatics Biotechnologies GmbH | N=145 --> 400
    Enrollment change • Checkpoint inhibition • First-in-human
    |
    IMA401 • IMA402
    21d
    A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer. (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Outpace Bio, Inc.
    New P1 trial • Platinum resistant
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    BRCA2 mutation • BRCA1 mutation
    28d
    AFPᶜ³³²T in Advanced HCC (clinicaltrials.gov)
    P1, N=39, Completed, Adaptimmune | Active, not recruiting --> Completed
    Trial completion
    |
    AFP (Alpha-fetoprotein)
    |
    ADP-A2AFP
    29d
    A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, Ruijin Hospital
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • HLA-DPB1 (Major Histocompatibility Complex, Class II, DP Beta 1)
    |
    KRAS mutation • NRAS mutation • RAS mutation • HRAS mutation • KRAS G12 • NRAS G12
    1m
    NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov)
    P1, N=2, Completed, Sun Yat-sen University | Active, not recruiting --> Completed | N=20 --> 2 | Trial completion date: May 2024 --> Apr 2026
    Trial completion • Enrollment change • Trial completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • TAEST16001
    1m
    Phase II Study of TAEST16001 in Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=8, Terminated, Sun Yat-sen University | N=70 --> 8 | Trial completion date: Sep 2024 --> Aug 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jul 2025; The study was terminated due to initiation of a new clinical trial with an updated study design.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001
    2ms
    MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial. (PubMed, Nat Med)
    No further DLTs occurred in the RP2D range with dexamethasone premedication. These findings show that the bispecific TCER platform has a manageable safety profile with mostly transient adverse events and promising antitumor activity at the RP2D of IMA401 with or without pembrolizumab. ClinicalTrials.gov identifier: NCT05359445 .
    P1 data • Journal • First-in-human
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    Keytruda (pembrolizumab) • dexamethasone • IMA401
    2ms
    The Landscape of Clinical Trials for TCR-T Cell Therapy. (PubMed, Am J Clin Oncol)
    NY-ESO-1 is the most prominent target, followed by MAGE-A4, KRAS, PRAME, HPV16 E6/E7, and HBV surface antigen, with letetresgene autoleucel and LioCyx-M004 being the most investigated TCR-T products. Collectively, TCR-T therapy is a promising field in tumor immunotherapy with continuous research investment and advancing clinical progress.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    letetresgene autoleucel (GSK3377794) • LioCyx-M
    2ms
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Southern California | Suspended --> Recruiting | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2026 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
    |
    HER-2 negative
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    2ms
    KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma) (clinicaltrials.gov)
    P1, N=30, Recruiting, TCRx Therapeutics Co.Ltd
    New P1 trial
    |
    tirbanibulin oral (KX-01 oral)
    2ms
    C2025-009-01: A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Beijing DCTY Biotech Co.,Ltd. | N=110 --> 18 | Trial completion date: May 2028 --> Aug 2028 | Trial primary completion date: May 2028 --> Aug 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12
    2ms
    NT-175-201: A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov)
    P1, N=45, Recruiting, AstraZeneca | Trial primary completion date: Sep 2028 --> Jul 2029
    Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    cyclophosphamide • fludarabine IV • NT-175