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    DRUG:

    TORL-1-23

    i
    Other names: TORL-1-23
    Company:
    TORL Biotherap
    Drug class:
    Microtubule inhibitor, CLDN6-targeted antibody-drug conjugate
    Related drugs:
    18d
    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)
    |
    TORL-1-23 • Neulasta (pegfilgrastim)
    1m
    CATALINA-2: a Phase 2 Study of TORL-1-23 in Advanced Ovarian Cancer. (clinicaltrials.gov)
    P2, N=230, Not yet recruiting, TORL Biotherapeutics, LLC
    New P2 trial • Metastases
    |
    CLDN6 (Claudin 6) • PROC (Protein C, Inactivator Of Coagulation Factors Va And VIIIa)
    |
    CLDN6 expression
    |
    TORL-1-23 • Neulasta (pegfilgrastim)
    over1year
    FIRST-IN-HUMAN PHASE 1 STUDY OF TORL-1-23, A NOVEL CLAUDIN 6 (CLDN6) TARGETED ANTIBODY DRUG CONJUGATE (ADC) IN PATIENTS WITH OVARIAN CANCER (IGCS 2023)
    19 patients with platinum-resistant/refractory ovarian cancer were evaluated across 8 dose levels (0.2 to 2.4 mg/kg IV every 3 weeks, 21 day cycles) (data cutoff 01APR2023). Most pts had ≥ 3 prior treatment lines in the metastatic setting. The most common treatment-related adverse events were Gr1 peripheral neuropathy (n=3), Gr1/2 fatigue (n=2), and Gr1 nausea (n=2).
    Clinical • P1 data
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression
    |
    TORL-1-23
    over1year
    First-in-human phase I study of a novel claudin 6 (CLDN6) targeted antibody drug conjugate (ADC) TORL-1-23 (ESMO 2023)
    Conclusions In participants with heavily-pretreated CLDN6-expressing ovarian cancer, the novel TORL-1-23 ADC has a favorable safety/tolerability profile and encouraging antitumor activity in a phase 1 dose finding study. Further evaluation in ovarian cancer and other CLDN6+ cancers is warranted.
    P1 data
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression
    |
    TORL-1-23
    over1year
    Initial results of dose finding in a first-in-human phase 1 study of a novel Claudin 6 (CLDN6) targeted antibody drug conjugate (ADC) TORL-1-23 in patients with advanced solid tumors. (ASCO 2023)
    TORL-1-23 has a favorable safety/tolerability profile and PK characteristics with preliminary antitumor activity in pts with heavily-pretreated CLDN6-expressing ovarian and testicular cancers. Doses above the historic MTD for MMAE containing ADCs may be explored given the safety/tolerability and PK data observed up to 2.4 mg/kg. Dose finding is ongoing to identify the MTD and optimal doses for subsequent development.
    Clinical • P1 data • Metastases
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 expression
    |
    TORL-1-23