^
    9d
    Sequential HIPEC, Claudin18.2-targeted therapy, and CapeOx chemotherapy leading to resolution of peritoneal metastases and curative resection in gastric cancer: a case report and literature review. (PubMed, Front Immunol)
    This study presents a case of Claudin18.2-positive advanced gastric adenocarcinoma with peritoneal metastasis treated with a multimodal regimen: HIPEC, systemic CapeOx chemotherapy, and Claudin18.2-targeted therapy (ASKB589)...At 893 days post-diagnosis, the patient remains disease-free (PFS/DFS: 893/573 days) on adjuvant capecitabine...However, the absence of cytoreductive surgery and single-case limitations necessitate validation through randomized trials. Future research should prioritize biomarker-driven HIPEC protocols (e.g., nanoparticle-enhanced Claudin18.2-targeted delivery) and dynamic monitoring of Claudin18.2 expression during therapy.
    Review • Journal
    |
    CLDN18 (Claudin 18) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 negative • HER-2 negative + CLDN18.2 positive
    |
    capecitabine • ASKB589
    3ms
    A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=199, Active, not recruiting, Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Trial primary completion date: Dec 2024 --> Oct 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    ASKB589
    3ms
    ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer. (clinicaltrials.gov)
    P1/2, N=62, Active, not recruiting, AskGene Pharma, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2025 --> Oct 2025
    Enrollment closed • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Tyvyt (sintilimab) • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • ASKB589
    over1year
    ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma (clinicaltrials.gov)
    P3, N=780, Recruiting, AskGene Pharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • ASKB589
    almost2years
    ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced, and Unresectable G/GEJ Cancer (clinicaltrials.gov)
    P3, N=780, Not yet recruiting, AskGene Pharma, Inc.
    New P3 trial • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • ASKB589
    2years
    A phase Ib/II study of ASKB589 (anti-Claudin 18.2 [CLDN18.2] monoclonal antibody) combined with CAPOX and PD-1 inhibitor as first-line treatment for locally advanced, relapsed and metastatic gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma. (ASCO-GI 2024)
    We report preliminary safety and efficacy data from an ongoing Phase Ib/II, dose-escalation and expansion study of ASKB589 combined with capecitabine, oxaliplatin(CAPOX) and Sintilimab as first-line treatment of G/GEJ adenocarcinoma (NCT05632939). ASKB589 combined with CAPOX and PD-1 inhibitor has manageable safety and promising antitumor activity. 6mg/kg is chosen as the recommended dose in subsequent studies. Clinical trial information: NCT05632939.
    Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Tyvyt (sintilimab) • capecitabine • oxaliplatin • ASKB589
    almost3years
    ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer. (clinicaltrials.gov)
    P1/2, N=57, Recruiting, AskGene Pharma, Inc. | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Feb 2026 | Trial primary completion date: Dec 2023 --> Feb 2025
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Tyvyt (sintilimab) • capecitabine • oxaliplatin • ASKB589
    almost3years
    A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=214, Recruiting, Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Nov 2023 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Dec 2024
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    ASKB589
    almost3years
    A phase I/II study of ASKB589 (anti-claudin 18.2 [CLDN18.2] monoclonal antibody) in patients with solid tumors. (ASCO-GI 2023)
    In Part B, pts with gastric/gastro-esophageal junction (G/GEJ) cancers received ASKB589 IV at doses of 3, 6, 10 or 15 mg/kg Q3W in combination with capecitabine plus oxaliplatin. ASKB589 showed a manageable safety profile up to doses of 20 mg/kg and promising antitumor activity, both as monotherapy and in combination with chemotherapy. Clinical trial information: NCT04632108.
    Clinical • P1/2 data
    |
    CLDN18 (Claudin 18)
    |
    capecitabine • oxaliplatin • ASKB589
    3years
    ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer. (clinicaltrials.gov)
    P1/2, N=57, Not yet recruiting, AskGene Pharma, Inc.
    New P1/2 trial • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    Tyvyt (sintilimab) • capecitabine • oxaliplatin • ASKB589