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Gastric CancerPhase 2GAMBITNCT07143604

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

A Phase 2 study testing AZD0901 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 13 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AZD0901
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
13 sitesRussia
Study dates
29 Aug 2025to 28 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Russia13 sites

  • Research Site

    Chelyabinsk, 454092

  • Research Site

    Krasnoyarsk, 660133

  • Research Site

    Kuzmolovskiy, 188663

  • Research Site

    Moscow, 111123

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 115533

  • Research Site

    Moscow, 125284

  • Research Site

    Moscow, 142770

  • Research Site

    Moscow, 143423

  • Research Site

    Nizhny Novgorod, 603126

  • Research Site

    Saint Petersburg, 197022

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Volgograd, Unk

Other trials in Russia

About this study

Official 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

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.

Read the detailed description

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.

Being tested
AZD0901
Keywords
Gastric cancer, Gastroesophageal junction cancer, Claudin 18.2, AZD0901
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD0901Drug

    Also called Sonesitatug Vedotin

    Participants will receive AZD0901 IV, Q3W

Study groups in NCT07143604
Study groupRoleWhat they receive
AZD0901ExperimentalParticipants will receive AZD0901 IV, Q3W
Receives: Drug: AZD0901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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

    Measured: At month 6 after date of first dose

Secondary outcomes (6)

  1. Progression Free Survival (PFS)

    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

    Measured: 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

  2. Overall Survival (OS)

    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

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

  3. Disease control rate (DCR) at 12 weeks

    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

    Measured: At 12 weeks after date of first dose

  4. Duration of Response (DoR)

    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.

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

  5. Time to Response (TTR)

    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.

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

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

    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.

    Measured: From the time of ICF signature up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start29 Aug 2025
  3. Primary completion14 Aug 2026
  4. Study completion28 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will receive AZD0901 IV, Q3W
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143604
Sponsor's protocol ID
AZ-RU-00007
Acronym
GAMBIT
Status last verified
Sep 2026
First submitted
20 Aug 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0901 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 13 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: At month 6 after date of first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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