Master protocol of novel combinations in participants with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Phase 1

Recruiting

• Conditions: ocally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma; MedDRA version: 20.0Level: PTClassification code: 10001150Term: Adenocarcinoma gastric Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10066354Term: Adenocarcinoma of the gastroesophageal junction Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-510977-27-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

18 years or older at the time of signing the ICF., Body weight > 35 kg., Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma., Has measurable target disease assessed by the Investigator based on RECIST 1.1., ECOG PS 0 or 1., Life expectancy of at least 12 weeks., Adequate organ and bone marrow function.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months);Secondary Objective: To evaluate the DoR (Duration of response), PFS (progression free survival), OS (overall survival), safety and tolerability, PK and immunogenicity of novel agent plus chemotherapy;Primary end point(s): ORR in response evaluable set, PFS6 in full analysis set

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):DoR per RECIST 1.1 based on Investigator assessment.;Secondary end point(s):PFS per RECIST 1.1 as assessed by the Investigator.;Secondary end point(s):OS.;Secondary end point(s):Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.;Secondary end point(s):Incidences of ADAs against novel agent in serum.;Secondary end point(s):Serum concentrations of novel agent and derived PK parameters.