Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma MedDRA version: 20.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AZD2936
Product Code: AZD2936
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: AZD2936
CAS Number: 2640305-01-5
Current Sponsor code: AZD2936
Other descrip
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • DoR per RECIST 1.1 based on Investigator assessment. • PFS per RECIST 1.1 as assessed by the Investigator. • OS. • Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG. • Serum concentrations of novel agent and derived PK parameters. • Incidences of ADAs against novel agent in serum.;Timepoint(s) of evaluation of this end point: Until end of study | — |
Countries
China, Japan, Korea, Republic of, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactUnidad de Investigación Clínica
AstraZeneca AB
Outcome results
None listed