Trial · NCT06346392
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
NCT06346392, Phase 3, Active not recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT06346392. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06346392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT06346392
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 594 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Interventions
- AZD0901, AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan, TAS-102, Apatinib
- First posted
- 2024-04-04
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) in all randomized participants | From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years). | The analysis will include all randomized participants. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Primary | Overall Survival (OS) for 3L+ participants | From date of first dose/randomisation until the date of death due to any cause (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | OS in all randomized participants | From date of first dose/randomisation until the date of death due to any cause (approximately 3 years). | The analysis will include all randomized participants. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | PFS for 3L+ participants | From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | Objective Response Rate (ORR) in all randomized participants | From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). | ORR is defined as the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1. |
| Secondary | ORR for 3L+ participants | From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy, with measurable disease at baseline |
| Secondary | Duration of Response (DoR) in all randomized participants | From the date of first documented confirmed response until date of documented progression (approximately 3 years). | The analysis will include all randomized participants with measurable disease at baseline who have a confirmed response. All events after achieving confirmed response will be included, regardless of whether the participant withdraws from therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1. |
| Secondary | Serum concentrations of AZD0901, total antibody and MMAE | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To characterise the PK of AZD0901 in participants. |
| Secondary | Status of ADA to AZD0901 | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To determine the immunogenicity of AZD0901 in participants. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs | From start through 30 days post treatment completion and follow up for 90 days. | To assess the safety and tolerability of AZD0901 as compared with Investigator's choice of therapy in all randomized participants who have received at least one dose of study intervention |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06346392
GET https://conductscience.org/api/trials/v1/NCT06346392/registered