A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin 18.2 (CLARITY-Gastric 01)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508276-11-00

Acronym

D9802C00001

Enrollment

Registered

2024-07-25

Start date

2025-01-17

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer, Advanced/Metastatic Gastric cancer, Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Brief summary

PFS in all randomized participants (BICR), OS for 3L+ participants

Detailed description

OS in all - time from randomization until the date of death due to any cause., PFS for 3L+ participants- time from randomization until progression per RECIST 1.1 asassessed by BICR or death due to any cause., ORR in all- the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1., ORR for 3L+ participants, DoR in all- the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause., DoR for 3L+ participants, Serum concentrations of AZD0901, total antibody and MMAE, and PK parameters, Presence of ADAs against AZD0901 in serum, Incidence of AEs and SAEs.

Interventions

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGIrinotecan Bendalis 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGBendadocel 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGDocetaxel Hikma 80 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCyramza 10 mg/ml concentrate for solution for infusion

DRUGLonsurf 20 mg/8.19 mg film-coated tablets

DRUGAZD0901

DRUGPaclitaxel Bendalis 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGIrinotecan Accord

DRUG20 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS in all randomized participants (BICR), OS for 3L+ participants	—

Secondary

Measure	Time frame
OS in all - time from randomization until the date of death due to any cause., PFS for 3L+ participants- time from randomization until progression per RECIST 1.1 asassessed by BICR or death due to any cause., ORR in all- the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1., ORR for 3L+ participants, DoR in all- the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause., DoR for 3L+ participants, Serum concentrations of AZD0901, total antibody and MMAE, and PK parameters, Presence of ADAs against AZD0901 in serum, Incidence of AEs and SAEs.	—

Measure

Time frame

—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026