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    DRUG CLASS:

    5T4-targeted antibody-drug conjugate

    Related drugs:
    10d
    ACR246-101: An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Recruiting, Hangzhou Adcoris Biopharmacy Co., Ltd | Not yet recruiting --> Recruiting | Initiation date: Mar 2024 --> Oct 2024 | Trial primary completion date: Jan 2025 --> Jun 2025
    Enrollment open • Trial initiation date • Trial primary completion date • Metastases
    15d
    A Study of JK06 in Patients with Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=155, Recruiting, Salubris Biotherapeutics Inc
    New P1/2 trial • Metastases
    22d
    First in Human Study of TUB-030 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=130, Not yet recruiting, Tubulis GmbH
    New P1/2 trial
    3ms
    Study of XB010 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=350, Recruiting, Exelixis
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    4ms
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Completed, Kirilys Therapeutics Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024
    Trial completion • Trial completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    ASN004
    7ms
    Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers (clinicaltrials.gov)
    P1, N=0, Withdrawn, Weill Medical College of Cornell University | N=30 --> 0 | Initiation date: Jun 2023 --> Nov 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2024 --> Dec 2025
    Enrollment change • Trial initiation date • Trial withdrawal • Trial primary completion date • Combination therapy
    |
    Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
    9ms
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=19, Active, not recruiting, Kirilys Therapeutics Inc. | Recruiting --> Active, not recruiting | N=45 --> 19 | Trial completion date: Mar 2027 --> Sep 2024 | Trial primary completion date: Mar 2026 --> Jun 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    TPBG expression
    |
    ASN004
    9ms
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, NeoTX Therapeutics Ltd. | Phase classification: P1b --> P1 | Trial completion date: Aug 2025 --> Oct 2026 | Trial primary completion date: May 2025 --> Oct 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    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)
    9ms
    NT-NAP-102-1: Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=38, Completed, NeoTX Therapeutics Ltd. | Active, not recruiting --> Completed | Phase classification: P2a --> P2 | Trial completion date: Jul 2024 --> Jan 2024
    Trial completion • Phase classification • Trial completion date
    |
    docetaxel • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
    10ms
    Study of ACR246 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Not yet recruiting, Hangzhou Adcoris Biopharmacy Co., Ltd
    New P1 trial
    1year
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=60, Active, not recruiting, NeoTX Therapeutics Ltd. | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: May 2023 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    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)
    1year
    Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=45, Recruiting, Kirilys Therapeutics Inc. | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    TPBG (Trophoblast Glycoprotein)
    |
    TPBG expression
    |
    ASN004
    over1year
    Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Weill Medical College of Cornell University
    New P1 trial • Combination therapy
    |
    Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
    over1year
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=60, Active, not recruiting, NeoTX Therapeutics Ltd. | Trial completion date: May 2023 --> Aug 2023
    Trial completion date • Combination therapy • Metastases
    |
    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)
    2years
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=60, Active, not recruiting, NeoTX Therapeutics Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    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)
    2years
    NT-NAP-102-1: Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2a, N=35, Recruiting, NeoTX Therapeutics Ltd. | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor)
    |
    docetaxel • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
    3years
    [VIRTUAL] Preclinical Profile of SYD1875, a Novel Site- Specifically Conjugated Anti- 5T4 Antibody Drug Conjugate (ADC-USA 2021)
    Its preclinical profile supports the expectation that SYD1875 will be of benefit for a broad group of cancer patients. A first-in-human dose-finding trial is initiated to evaluate safety and explore efficacy (NCT04202705).
    Preclinical
    |
    TPBG (Trophoblast Glycoprotein)
    |
    SYD1875
    over3years
    ASN004, a 5T4-targeting scFv-Fc antibody-drug conjugate with high drug-to-antibody ratio, induces complete and durable tumor regressions in preclinical models. (PubMed, Mol Cancer Ther)
    In head-to-head studies, superior activity of ASN004 was demonstrated against trastuzumab-DM1, in a low-5T4/high-HER2 expressing gastric tumor model, and 10-fold greater potency was found for ASN004 against the 5T4-targeted ADC PF-06263507 in a lung tumor model. In marmoset monkeys, ASN004 was well tolerated at doses up to 1.5 mg/kg Q3W iv, and showed dose-dependent exposure, linear pharmacokinetics, and markedly low exposure of free payload drug. Taken together, these findings identify ASN004 as a promising new ADC therapeutic for clinical evaluation in a broad range of solid tumor types.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TPBG (Trophoblast Glycoprotein)
    |
    HER-2 expression • HER-2-H
    |
    Kadcyla (ado-trastuzumab emtansine) • ASN004 • PF-06263507