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Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Purpose

Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cadonilimab
AK117
Oxaliplatin
Tegafur-gimeracil-oteracil potassium
Docetaxel
5-Fluorouracil
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be able and willing to provide written informed consent. 18 to 75 years old. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ). Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer [AJCC]) Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Has adequate organ function. Exclusion Criteria: Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage. Is currently participating in a study of an investigational agent or using an investigational device. Has undergone major surgery within 30 days of Study Day 1. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Has received a live virus vaccine within 30 days of the planned first dose of study therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1 cohort 1

    Part 1 cohort 2

    Part 2 cohort 1

    Part 2 cohort 2

    Arm Description

    Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.

    Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.

    Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.

    Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.

    Outcomes

    Primary Outcome Measures

    Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
    Pathological complete response (pCR) rates
    pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes

    Secondary Outcome Measures

    Major pathological response(MPR) rates
    MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
    Tumor regression grade(TRG)
    R0 resection rate
    Tumor descending stage rate
    Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
    ORR
    EFS
    OS
    PK
    Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
    ADA
    Number of subjects with detectable anti-drug antibodies (ADA).

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 17, 2023
    Sponsor
    Akeso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960955
    Brief Title
    Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
    Official Title
    Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 20, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Akeso

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1 cohort 1
    Arm Type
    Experimental
    Arm Description
    Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
    Arm Title
    Part 1 cohort 2
    Arm Type
    Experimental
    Arm Description
    Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
    Arm Title
    Part 2 cohort 1
    Arm Type
    Experimental
    Arm Description
    Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
    Arm Title
    Part 2 cohort 2
    Arm Type
    Experimental
    Arm Description
    Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Cadonilimab
    Intervention Description
    IV infusion,Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    AK117
    Intervention Description
    IV infusion,Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Intervention Description
    IV infusion,Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Tegafur-gimeracil-oteracil potassium
    Intervention Description
    Oral,Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    IV infusion,Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    5-Fluorouracil
    Intervention Description
    IV infusion,Specified dose on specified days
    Primary Outcome Measure Information:
    Title
    Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
    Time Frame
    Up to approximately 2 years
    Title
    Pathological complete response (pCR) rates
    Description
    pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes
    Time Frame
    Up to approximately 2 years
    Secondary Outcome Measure Information:
    Title
    Major pathological response(MPR) rates
    Description
    MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
    Time Frame
    Up to approximately 2 years
    Title
    Tumor regression grade(TRG)
    Time Frame
    Up to approximately 2 years
    Title
    R0 resection rate
    Time Frame
    Up to approximately 2 years
    Title
    Tumor descending stage rate
    Description
    Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
    Time Frame
    Up to approximately 2 years
    Title
    ORR
    Time Frame
    Up to approximately 2 years
    Title
    EFS
    Time Frame
    Up to approximately 2 years
    Title
    OS
    Time Frame
    Up to approximately 2 years
    Title
    PK
    Description
    Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
    Time Frame
    Up to approximately 2 years
    Title
    ADA
    Description
    Number of subjects with detectable anti-drug antibodies (ADA).
    Time Frame
    Up to approximately 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be able and willing to provide written informed consent. 18 to 75 years old. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ). Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer [AJCC]) Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Has adequate organ function. Exclusion Criteria: Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage. Is currently participating in a study of an investigational agent or using an investigational device. Has undergone major surgery within 30 days of Study Day 1. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weifeng Song, MD
    Phone
    +86(0760)89873999
    Email
    clinicaltrials@akesobio.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Han Liang, MD

    12. IPD Sharing Statement

    Learn more about this trial

    Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

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