Health Trials

Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

ConditionsGastric CancerGastroesophageal Junction AdenocarcinomaEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving signed informed consent

Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.

Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma

Positive CLDN18.2 expression, as determined prospectively by central IHC testing

Disqualifiers

Known HER2-positive status

Significant or unstable gastric bleeding and/or untreated gastric ulcers.

Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.

CNS pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sonesitatug vedotin

    Drug

    Intravenous

  • Rilvegostomig

    Drug

    Intravenous

  • Nivolumab

    Drug

    Intravenous

  • Capecitabine

    Drug

    Oral

  • 5-Fluorouracil

    Drug

    Intravenous

  • Oxaliplatin

    Drug

    Intravenous

  • Zolbetuximab

    Drug

    Intravenous

  • Leucovorin

    Drug

    Intravenous

Treatment groups

2,130 Participants
are divided into 5 treatment groups
Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BExperimental treatment 3 interventions
Group C: Arm CActive comparator 5 interventions
Group D: Arm DExperimental treatment 2 interventions
Group E: Arm EActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) (Cohort 1 and Cohort 2)

PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.

Time frame
Up to approximately 5 years
2

Overall Survival (OS) (Cohort 1)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 5 years

Secondary outcomes

1

Overall Survival (OS) (Cohort 2)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 5 years
2

Overall Survival (OS) (Cohort 1)

OS is defined as time from randomisation until date of death due to any cause. Arm B versus C.

Time frame
Up to approximately 5 years
3

Progression Free Survival (PFS) (Cohort 1)

PFS is defined as time from randomisation until progression per RECIST 1.1 or death due to any cause, whichever occurs first. Arms B versus C.

Time frame
Up to approximately 5 years
4

Objective Response Rate (ORR) (Cohort 1 and Cohort 2)

ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1.

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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