AZD0901 (Sonesitatug vedotin) for Locally advanced unresectable or metastatic gastric adenocarcinoma | Locally advanced unresectable or metastatic gastroesophageal junction adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 18 years or older at the time of signing the ICF.\n- Body weight > 35 kg.\n- Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n- Has measurable target disease assessed by the Investigator based on RECIST 1.1.\n- ECOG PS 0 or 1.\n- Life expectancy of at least 12 weeks.\n- Adequate organ and bone marrow function.\n- Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 is open for recruitment"}

Exclusion criteria

• {"criterion_text":"- Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH) or indeterminate gastric or GEJ carcinoma.\n- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.\n- Participants with ascites which cannot be controlled with appropriate interventions.\n- Uncontrolled intercurrent illness.\n- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.\n- History of another primary malignancy.\n- Previous treatment with an immune-oncology agent.\n- Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C."}

Primary endpoints

• {"endpoint_text":"- ORR in response evaluable set","definition_or_measurement_approach":"Objective response rate assessed in the response-evaluable set; based on RECIST 1.1 (measurable disease required) as assessed by the Investigator."}
• {"endpoint_text":"- PFS6 in full analysis set","definition_or_measurement_approach":"Proportion of participants alive and progression-free at 6 months in the full analysis set; progression assessed per RECIST 1.1 by the Investigator."}

Secondary endpoints

• {"endpoint_text":"- DoR per RECIST 1.1 based on Investigator assessment.","definition_or_measurement_approach":"Duration of response assessed per RECIST 1.1 based on Investigator assessment."}
• {"endpoint_text":"- PFS per RECIST 1.1 as assessed by the Investigator.","definition_or_measurement_approach":"Progression-free survival assessed per RECIST 1.1 by the Investigator."}
• {"endpoint_text":"- OS.","definition_or_measurement_approach":"Overall survival (time from randomisation/enrolment to death from any cause)."}
• {"endpoint_text":"- Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.","definition_or_measurement_approach":"Safety assessments including adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), physical exams, laboratory tests, vital signs and 12-lead ECG."}
• {"endpoint_text":"- Incidences of ADAs against novel agent in serum.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADAs) measured in serum."}
• {"endpoint_text":"- Serum concentrations of novel agent and derived PK parameters.","definition_or_measurement_approach":"Pharmacokinetic assessment: serum concentrations of novel agent and derived PK parameters."}

Spain

Earliest CTIS Part Ii Submission Date

07-02-2024

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

807

Number Of Sites

7

Number Of Participants

8

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden