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    DRUG:

    sonesitatug vedotin (AZD0901)

    i
    Other names: AZD0901, CMG901, AZD-0901, CMG-901, AZD 0901, CMG 901
    Company:
    AstraZeneca, Keymed Biosciences, Lepu Med
    Drug class:
    Microtubule inhibitor, CLDN18.2-targeted antibody-drug conjugate
    Related drugs:
    15d
    CLARITY-Gastric 01: 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=572, Recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Sep 2026 | Trial primary completion date: Oct 2026 --> May 2026
    Trial completion date • Trial primary completion date
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    1m
    Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med)
    Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CDH6 (Cadherin 6) • CDH17 (Cadherin 17)
    |
    CLDN18.2 positive
    |
    Padcev (enfortumab vedotin-ejfv) • sonesitatug vedotin (AZD0901) • tecotabart vedotin (LM-302) • zelenectide pevedotin (BT8009) • SHR-A2102 • arcotatug tavatecan (IBI-343) • bulumtatug fuvedotin (9MW2821) • garetatug rezetecan (SHR-A1904) • raludotatug deruxtecan (DS-6000)
    2ms
    GAMBIT: A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 (clinicaltrials.gov)
    P2, N=33, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    sonesitatug vedotin (AZD0901)
    3ms
    GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial primary completion date
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    3ms
    GAMBIT: A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    sonesitatug vedotin (AZD0901)
    4ms
    CLARITY-Gastric 01: 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=572, Recruiting, AstraZeneca | Trial completion date: Oct 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    4ms
    GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    5ms
    A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, AstraZeneca
    New P2 trial
    |
    docetaxel • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    5ms
    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: Jan 2027 --> Jul 2027 | Trial primary completion date: Jan 2026 --> Jul 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)
    10ms
    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)
    11ms
    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)
    11ms
    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)