Gastric Cancer, Gastroesophageal Junction Cancer
Conditions
Keywords
Gastric cancer, Gastroesophageal junction cancer, Claudin 18.2, AZD0901
Brief 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.
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.
Interventions
DRUGAZD0901
Participants will receive AZD0901 IV, Q3W
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Intervention model description
Participants will receive AZD0901 IV, Q3W
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | At month 6 after date of first dose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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 | 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 |
| Overall Survival (OS) | From the date of assignment until the date of death from any cause, assessed up to 30 months | 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 |
| Disease control rate (DCR) at 12 weeks | At 12 weeks after date of first dose | 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 |
| Duration of Response (DoR) | From the date of first documented confirmed response until date of documented progression, assessed up to 30 months | 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. |
| Time to Response (TTR) | From the date of first dose to the first documented objective tumor response, assessed up to 30 months | 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. |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. | From the time of ICF signature up to 30 months | 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. |
Countries
Russia
Outcome results
None listed