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    DRUG CLASS:

    CLDN6-targeted antibody-drug conjugate

    Related drugs:
    3d
    FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=83, Recruiting, Axcynsis Therapeutics Pte Ltd | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • CLDN6 (Claudin 6)
    |
    EGFR mutation
    27d
    CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=60, Recruiting, TORL Biotherapeutics, LLC
    New P1/2 trial
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    CLDN6 (Claudin 6)
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    carboplatin • paclitaxel • ixotatug vedotin (TORL-1-23)
    2ms
    The KIF18A Inhibitor ATX020 Induces Mitotic Arrest and DNA Damage in Chromosomally Instable High-Grade Serous Ovarian Cancer Cells. (PubMed, Cells)
    Mechanistically, ATX020 blocks KIF18A's plus-end movement on spindle fibers, increasing spindle length, resulting in chromosomal mis-segregation, aneuploidy, and DNA damage. Our findings suggest that ATX020 inhibits CIN+ HGSOC cells mainly by inducing mitotic arrest and DNA damage, disrupting KIF18A's function crucial for mitosis.
    Journal
    |
    TP53 (Tumor protein P53) • KIF18A (Kinesin Family Member 18A)
    |
    TP53 mutation
    3ms
    Discovery of Kinesin KIF18A Inhibitor ATX020: Tactical Application of Silicon Atom Replacement. (PubMed, ACS Med Chem Lett)
    ATX020 is a potent KIF18A inhibitor with a high degree of kinesin selectivity, favorable in vitro and in vivo ADME properties, and robust efficacy in the OVCAR-3 cell-derived xenograft (CDX) model. A high-resolution crystal structure of the KIF18A-tubulin complex and an experimentally guided model of ATX020 bound to the complex are provided, supporting future structure-based drug design of KIF18A inhibitors.
    Journal
    |
    KIF18A (Kinesin Family Member 18A)
    6ms
    FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=83, Not yet recruiting, Axcynsis Therapeutics Pte Ltd | Initiation date: Aug 2025 --> Nov 2025
    Trial initiation date
    7ms
    Corneal pseudomicrocysts following claudin-6 antibody-drug conjugate infusion. (PubMed, Am J Ophthalmol Case Rep)
    Collagen and silicone punctal plugs were placed and the patient was started on preservative free artificial tears, topical loteprednol 0.5 %, later replaced with topical prednisolone acetate 1 % drops, and brimonidine 0.2 % in both eyes. Ocular symptoms and exam findings waxed and waned with continued infusions of the ADC. This case reports an incidence of corneal pseudomicrocysts associated with TORL-1-23 treatment, which should be recognized as a potential adverse effect of this novel therapy.
    Journal
    |
    CLDN6 (Claudin 6)
    |
    ixotatug vedotin (TORL-1-23)
    7ms
    REFMAL 823: A Study of DS-9606a in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=88, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed
    9ms
    TRIO-049: First in Human Study of TORL-1-23 in Participants With Advanced Cancer (clinicaltrials.gov)
    P1, N=90, Recruiting, TORL Biotherapeutics, LLC | Trial primary completion date: Apr 2025 --> Aug 2026 | Trial completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    ixotatug vedotin (TORL-1-23)
    10ms
    Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=256, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1 trial
    11ms
    TRIO-049: First in Human Study of TORL-1-23 in Participants with Advanced Cancer (clinicaltrials.gov)
    P1, N=90, Recruiting, TORL Biotherapeutics, LLC | Trial primary completion date: Nov 2024 --> Apr 2025
    Trial primary completion date
    |
    ixotatug vedotin (TORL-1-23)
    12ms
    FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=78, Not yet recruiting, Axcynsis Therapeutics Pte Ltd
    New P1 trial
    1year
    TORL123-002: CATALINA-2: a Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer. (clinicaltrials.gov)
    P2, N=230, Recruiting, TORL Biotherapeutics, LLC | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CLDN6 (Claudin 6) • PROC (Protein C, Inactivator Of Coagulation Factors Va And VIIIa)
    |
    ixotatug vedotin (TORL-1-23) • Neulasta (pegfilgrastim)