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NCT Number: NCT07143604

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

The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chelyabinsk, Russia

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About this study

This is a Phase II, single arm, open label, multicentre study, assessing the efficacy and safety of AZD0901 in participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. The results of the study will provide clinical data on efficacy and safety of an innovation drug in Russian Federation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.
  • Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
  • Must have at least one measurable lesion assessed by the Investigator based on RECIST 1.1.
  • ECOG performance status of 0 or 1.
  • Minimum life expectancy of ≥12 weeks.
  • Adequate organ and bone marrow function.
  • Minimum body weight of 40 kg.
  • Sex and Contraceptive Requirements.

Exclusion criteria

  • Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +.
  • Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
  • CNS metastases or CNS pathology.
  • Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
  • Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy.
  • History of thromboembolic events.

Treatment and study plan

AZD0901

Drug

Participants will receive AZD0901 IV, Q3W

Other names: Sonesitatug Vedotin

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: At month 6 after date of first dose

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator per RECIST 1.1 to all dosed participants

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months

    PFS is defined as time from date of first dose until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause

  2. Overall Survival (OS)

    Time frame: From the date of assignment until the date of death from any cause, assessed up to 30 months

    OS is defined as the time from date of first dose of IMP until the date of death due to any cause. The analysis will include all dosed participants. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy

  3. Disease control rate (DCR) at 12 weeks

    Time frame: At 12 weeks after date of first dose

    DCR at 12 weeks is defined as the percentage of participants who have at least 1 visit response of confirmed CR or PR or who have stable disease (SD) per RECIST 1.1 for at least 11 weeks as assessed by the investigator to all dosed participants

  4. Duration of Response (DoR)

    Time frame: From the date of first documented confirmed response until date of documented progression, assessed up to 30 months

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death due to any cause. Analysis will include all dosed participants, with measurable disease at baseline who have a response, regardless of whether the participant withdraws from therapy, receives another anticancer treatment, or clinically progresses prior to PD.

  5. Time to Response (TTR)

    Time frame: From the date of first dose to the first documented objective tumor response, assessed up to 30 months

    TTR is defined as the time from the start of the treatment to the first documented objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST 1.1. Analysis will include all dosed participants, with measurable disease at baseline who have a response, regardless of whether the participant withdraws from therapy, receives another anticancer treatment, or clinically progresses prior to PD.

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

    Time frame: From the time of ICF signature up to 30 months

    Treatment-emergent adverse events are defined as adverse events or worsening of pre-existing events with an onset date on or after first dose of IMP and within 90 (+ 7) days after last dose of study intervention or up to the day prior to start of subsequent therapy, whichever comes first.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Acronym: GAMBIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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