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

Phase 1

• Conditions: ocally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma; MedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-002840-29-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.
• Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
• 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.

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<br><br>PFS6 in full analysis set;Timepoint(s) of evaluation of this end point: At a minimum of 6 months following the last participant’s first dose in the substudy

Secondary Outcome Measures

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