CLDN18.2 ADC · ADC

AZD0901

5 active trials, targeting Claudin 18.2. Not approved for any biomarker on marked.bio yet.

Also known as CMG901.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
Claudin 18.2 expression 5 6 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of AZD0901.

  1. AstraZeneca 5

Trials

Status

5 of 6 trials shown

  1. Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

    Recruiting Phase 3 AstraZeneca Started 2026Primary completion 2029-08 NCT07431281

    AZD0901Rilvegostomignivolumabcapecitabinefluorouraciloxaliplatinzolbetuximab FDA EUleucovorin

    Positive CLDN18.2 expression, as determined prospectively by central IHC testing

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

  2. 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

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-05 NCT06346392

    AZD0901ramucirumabpaclitaxeldocetaxelirinotecantrifluridine/tipiracilapatinib

    (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer

  3. A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

    Recruiting Phase 2 AstraZeneca Started 2025Primary completion 2027-11 NCT07069712

    AZD0901Rilvegostomigtrastuzumab deruxtecancapecitabinefluorouracilFLOT Chemotherapyleucovorin

    Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2

    Claudin 18.2 expressionGastroesophageal Adenocarcinoma

  4. A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

    Active, not recruiting Phase 2 AstraZeneca Started 2025Primary completion 2026-08 NCT07143604

    AZD0901

    …advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer

  5. AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

    Recruiting Phase 2 AstraZeneca Started 2023Primary completion 2026-11 NCT06219941

    AZD0901fluorouracilleucovorinirinotecanliposomal irinotecangemcitabine

    Participants who are CLDN18.2 positive.

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma