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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Participants will receive AZD0901 IV, Q3W
Research Site
Chelyabinsk, Russia
RECRUITINGResearch Site
Krasnoyarsk, Russia
NOT_YET_RECRUITINGObjective Response Rate (ORR)
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
Time frame: At month 6 after date of first dose
Progression Free Survival (PFS)
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
Time frame: 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
Overall Survival (OS)
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
Time frame: From the date of assignment until the date of death from any cause, assessed up to 30 months
Disease control rate (DCR) at 12 weeks
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
Time frame: At 12 weeks after date of first dose
Duration of Response (DoR)
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.
AstraZeneca Clinical Study Information Center
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Research Site
Kuzmolovskiy, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Moscow, Russia
RECRUITINGResearch Site
Nizhny Novgorod, Russia
RECRUITING...and 4 more locations
Time frame: From the date of first documented confirmed response until date of documented progression, assessed up to 30 months
Time to Response (TTR)
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.
Time frame: From the date of first dose to the first documented objective tumor response, assessed up to 30 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
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.
Time frame: From the time of ICF signature up to 30 months