AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
← catalyst calendarNCT06219941 · readout in 90 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
226estimated
Sites
52
Countries
Australia, Canada, China +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-13 | actual | When the study began enrolling |
| Primary completion | 2026-11-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-28 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Gastric Cancer
- Gastroesophageal Junction Cancer
- Biliary Tract Cancer
- Pancreatic Ductal Adenocarcinoma
Interventions
- Drug: AZD0901 — also filed as CMG901
- Drug: 5-Fluorouracil — also filed as 5-FU
- Drug: Leucovorin — also filed as LV
- Drug: l-leucovorin — also filed as I-LV
- Drug: Irinotecan — also filed as Camptosar
- Drug: Nanoliposomal Irinotecan — also filed as ONIVYDE
- Drug: Gemcitabine — also filed as Gemzar
Primary outcomes
what the primary-completion date above is the date OFIncidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.
measured 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
Objective Response Rate (ORR).
measured From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
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