ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer 
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  • ||||||||||  SDP03923-000-9106 / Jiangsu Hengrui Pharma
    SDP03923-000-9106, a novel and optimized LIV-1 ADC with superior anti-tumor efficacy in breast cancer xenograft models (Section 21) -  Mar 5, 2024 - Abstract #AACR2024AACR_5302;    
    In summary, SDP03923-000-9106 is a novel LIV-1 targeted ADC with a highly permeable payload demonstrating great anti-tumor activity across multiple types of tumors in preclinical studies. The promising preclinical data support advancing SDP03923-000-9106 into clinical testing, and Investigational New Drug (IND) application to NMPA has been submitted.
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Journal:  Expression of cell surface zinc transporter LIV1 in triple negative breast cancer is an indicator of poor prognosis and therapy failure. (Pubmed Central) -  Feb 12, 2024   
    The promising preclinical data support advancing SDP03923-000-9106 into clinical testing, and Investigational New Drug (IND) application to NMPA has been submitted. Recently, in the United States of America, FDA approved the use of a new drug targeting LIV1, antibody drug conjugate SGN-LIV1A for treatment of TNBC patients...Finally, TNBC patients with 3+ staining intensity showed poor survival (4.44 year) as compared to patients with 2+
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Trial completion date, Trial termination, Trial primary completion date, Metastases:  SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) -  Dec 27, 2023   
    P2,  N=205, Terminated, 
    Recently, in the United States of America, FDA approved the use of a new drug targeting LIV1, antibody drug conjugate SGN-LIV1A for treatment of TNBC patients...Finally, TNBC patients with 3+ staining intensity showed poor survival (4.44 year) as compared to patients with 2+ Trial completion date: Jul 2025 --> Nov 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Nov 2023; Study closed due to portfolio prioritization
  • ||||||||||  LIV-1 CAR-T / CRISPR Therap, ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
    Allogeneic CAR T cells targeting Liv-1 for breast cancer (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_688;    
    Its specific expression in breast cancer, as opposed to other tissues, reduces the risk of off-target toxicity. We have demonstrated that anti-Liv1 CAR T cells can be produced with potent in vitro and in vivo CAR T cell activity against multiple breast cancer cell lines.
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Enrollment closed, Enrollment change, Metastases:  SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) -  Jul 14, 2023   
    P2,  N=205, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | N=414 --> 205
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Trial completion, Trial completion date:  SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) -  Mar 7, 2023   
    P1,  N=290, Completed, 
    Trial primary completion date: Apr 2023 --> Mar 2024 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2023
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Enrollment closed, Enrollment change, Trial primary completion date:  SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) -  Dec 21, 2022   
    P1,  N=290, Active, not recruiting, 
    N=264 --> 414 Recruiting --> Active, not recruiting | N=448 --> 290 | Trial primary completion date: Dec 2022 --> Mar 2023
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
    Review, Journal, IO biomarker:  Zinc transporter LIV1: A promising cell surface target for triple negative breast cancer. (Pubmed Central) -  Oct 2, 2022   
    Early clinical trial results reveal that this novel agent reduces tumor burden by inducing mitotic arrest, immunomodulation, and immunogenic cell death, warranting further investigation of SGN-LIV1A in combination with immuno-oncology agents. Priming the patient's immune response in combination with SGN-LIV1A could eventually change the landscape for the TNBC patient population.
  • ||||||||||  Review, Journal, BRCA Biomarker:  From seaside to bedside: Current evidence and future perspectives in the treatment of breast cancer using marine compounds. (Pubmed Central) -  Sep 29, 2022   
    A deeper knowledge of the mechanism of action and of the potential predictive factors for response to marine-derived drugs is important for their rational and effective use, alone or in combination. In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics.
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Trial primary completion date:  SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) -  Aug 3, 2022   
    P1,  N=448, Recruiting, 
    In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics. Trial primary completion date: Jul 2022 --> Dec 2022
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Trial completion date, Trial primary completion date, Metastases:  SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) -  Aug 3, 2022   
    P2,  N=264, Recruiting, 
    Trial primary completion date: Jul 2022 --> Dec 2022 Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: Aug 2022 --> May 2024
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Review, Journal:  Actively Targeted Nanomedicines in Breast Cancer: From Pre-Clinal Investigation to Clinic. (Pubmed Central) -  Mar 11, 2022   
    In this work, all these active targeted nanomedicines are discussed, analyzing their advantages and disadvantages over conventional chemotherapy as well as the challenges involved in their lab to clinical translation. In addition, examples of formulations developed and evaluated at the preclinical level are also discussed.
  • ||||||||||  Biomarker, Trial completion date, Trial primary completion date:  I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) -  Aug 27, 2021   
    P2,  N=4000, Recruiting, 
    N=161 --> 211 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Feb 2022 --> Apr 2023 Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
    [VIRTUAL] Weekly ladiratuzumab vedotin monotherapy for metastatic triple-negative breast cancer () -  Jul 22, 2021 - Abstract #ESMO2021ESMO_1644;    
    P1
    LV 1.25 mg/kg q1w is associated with a manageable safety profile and favorable preliminary efficacy data in patients with 2L mTNBC. Further studies of LV q1w in patients with breast cancer and other tumors are underway., and provided by Sandra Hackelberg of MMS Holdings, Inc.
  • ||||||||||  [VIRTUAL] Module 3: Immune Checkpoint Inhibitors and Other Novel Strategies for the Treatment of Triple-Negative Breast Cancer (TNBC) () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5853;    
    Further studies of LV q1w in patients with breast cancer and other tumors are underway., and provided by Sandra Hackelberg of MMS Holdings, Inc. Available results from the Phase III KEYNOTE-522 and IMpassion031 trials documenting the benefit of neoadjuvant pembrolizumab or atezolizumab, respectively, with chemotherapy versus chemotherapy alone for TNBC Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC (mTNBC) Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination Key efficacy and safety findings supporting the recent FDA approval of pembrolizumab in combination with chemotherapy for patients with previously untreated PD-L1-positive mTNBC (KEYNOTE-355 trial); effect of chemotherapy partner and previous chemotherapy exposure on outcomes FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive mTNBC; optimal integration into practice Mechanism of action, available data and recent FDA approval of sacituzumab govitecan; biomarker findings from the confirmatory Phase III ASCENT study and optimal integration into mTNBC management algorithms Other promising novel agents and strategies under investigation for TNBC (eg, ladiratuzumab vedotin, datopotamab deruxtecan)
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
    Trial completion date, Trial primary completion date:  SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) -  Apr 22, 2021   
    P1,  N=508, Recruiting, 
    Available results from the Phase III KEYNOTE-522 and IMpassion031 trials documenting the benefit of neoadjuvant pembrolizumab or atezolizumab, respectively, with chemotherapy versus chemotherapy alone for TNBC Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC (mTNBC) Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination Key efficacy and safety findings supporting the recent FDA approval of pembrolizumab in combination with chemotherapy for patients with previously untreated PD-L1-positive mTNBC (KEYNOTE-355 trial); effect of chemotherapy partner and previous chemotherapy exposure on outcomes FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive mTNBC; optimal integration into practice Mechanism of action, available data and recent FDA approval of sacituzumab govitecan; biomarker findings from the confirmatory Phase III ASCENT study and optimal integration into mTNBC management algorithms Other promising novel agents and strategies under investigation for TNBC (eg, ladiratuzumab vedotin, datopotamab deruxtecan) Trial completion date: Mar 2022 --> Jun 2023 | Trial primary completion date: Apr 2021 --> Jul 2022
  • ||||||||||  ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
    [VIRTUAL] Open-label, phase II study of ladiratuzumab vedotin (LV) for castration-resistant prostate cancer (SGNLVA-005, trial-in-progress). () -  Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_703;    
    P2
    Study objectives include objective tumor response rate per RECIST 1.1 and prostate-specific antigen (PSA) response rate per Prostate Cancer Clinical Trials Working Group 3 (both primary); safety and tolerability, disease control rate, duration of response, progression-free and overall survival, and pharmacokinetics and immunogenicity (all secondary); and pharmacodynamics. Study accrual is ongoing in the USA, Italy, South Korea, Taiwan, Australia, and the UK.