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    DRUG:

    sonesitatug vedotin (AZD0901)

    i
    Company:
    AstraZeneca, Keymed Biosciences, Lepu Med
    Drug class:
    Microtubule inhibitor, CLDN18.2-targeted antibody-drug conjugate
    Related drugs:
    2ms
    KYM901: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901 (clinicaltrials.gov)
    P1, N=176, Completed, Keymed Biosciences Co.Ltd | Recruiting --> Completed | Trial completion date: Oct 2024 --> Apr 2024
    Trial completion • Trial completion date
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    sonesitatug vedotin (AZD0901)
    3ms
    CLARITY-PanTumor01: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov)
    P2, N=190, Recruiting, AstraZeneca | N=123 --> 190 | Trial primary completion date: May 2025 --> Dec 2025
    Enrollment change • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    3ms
    GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=240, Recruiting, AstraZeneca | Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Sep 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18)
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    3ms
    Claudin 18.2-targeting antibody-drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial. (PubMed, Lancet Oncol)
    CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.
    P1 data • Journal
    |
    CLDN18 (Claudin 18)
    |
    sonesitatug vedotin (AZD0901)
    7ms
    Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med)
    The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CLDN1 (Claudin 1)
    |
    Vyloy (zolbetuximab-clzb) • sonesitatug vedotin (AZD0901) • ALE.C04 • osemitamab (TST001) • arcotatug tavatecan (IBI-343)
    8ms
    CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors. (PubMed, Cell Rep Med)
    CMG901's favorable preclinical profile supports its entry into the human clinical study. CMG901 is currently under phase 3 investigation in patients with advanced gastric/gastroesophageal junction adenocarcinoma expressing Claudin18.2 (NCT06346392).
    Journal
    |
    CLDN18 (Claudin 18)
    |
    sonesitatug vedotin (AZD0901)
    1year
    AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=589, Recruiting, AstraZeneca
    New P3 trial
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    over1year
    AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov)
    P2, N=123, Recruiting, AstraZeneca
    New P2 trial • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    over1year
    Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=240, Recruiting, AstraZeneca | N=80 --> 240
    Enrollment change • Metastases
    |
    CLDN18 (Claudin 18)
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    over1year
    Optimism Surrounds Claudin 18.2 ADC. (PubMed, Cancer Discov)
    Historically, progression-free survival (PFS) hovers around 7 months and overall survival (OS) around 14 to 16 months. However, depending on the dose, PFS with CMG901 ranged from 3.3 to 14.5 months, and OS ranged from 8.5 months to not reached, after a median follow up of 6 months.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    sonesitatug vedotin (AZD0901)
    over1year
    A phase 1 trial of claudin 18.2-specific antibody-drug conjugate CMG901 in patients with advanced gastric/gastroesophageal junction cancer (ASCO Plenary Nov 2023)
    NCT04805307
    Clinical • P1 data • Metastases
    |
    CLDN18 (Claudin 18)
    |
    sonesitatug vedotin (AZD0901)
    over2years
    Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901 (clinicaltrials.gov)
    P1, N=162, Recruiting, Keymed Biosciences Co.Ltd | Trial completion date: Oct 2022 --> Oct 2024 | Trial primary completion date: May 2022 --> May 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    sonesitatug vedotin (AZD0901)
    over2years
    A phase 1a dose-escalation, multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/refractory solid tumors. (ASCO-GI 2023)
    CMG901 was well-tolerated with preliminary promising clinical efficacy in patients with CLDN18.2-positive gastric/GEJ cancer. The Phase 1b dose-expansion trial in gastric/GEJ adenocarcinoma, pancreatic cancer, and other solid tumors is rapidly enrolling, with multiple pivotal (Phases 2 and 3) trials planned. Clinical trial information: NCT04805307.
    Clinical • P1 data
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive
    |
    sonesitatug vedotin (AZD0901)