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

Sponsor

Akeso (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05960955

Collaborator

(none)

Enrollment

Arms

48.3

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Gastric or Gastroesophageal Junction Adenocarcinoma	Drug: Cadonilimab Drug: AK117 Drug: Oxaliplatin Drug: Tegafur-gimeracil-oteracil potassium Drug: Docetaxel Drug: 5-Fluorouracil	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 cohort 1 Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.	Drug: Cadonilimab IV infusion,Specified dose on specified days Drug: Oxaliplatin IV infusion,Specified dose on specified days Drug: Tegafur-gimeracil-oteracil potassium Oral,Specified dose on specified days
Experimental: Part 1 cohort 2 Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.	Drug: Cadonilimab IV infusion,Specified dose on specified days Drug: AK117 IV infusion,Specified dose on specified days Drug: Oxaliplatin IV infusion,Specified dose on specified days Drug: Tegafur-gimeracil-oteracil potassium Oral,Specified dose on specified days
Experimental: Part 2 cohort 1 Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.	Drug: Cadonilimab IV infusion,Specified dose on specified days Drug: Oxaliplatin IV infusion,Specified dose on specified days Drug: Docetaxel IV infusion,Specified dose on specified days Drug: 5-Fluorouracil IV infusion,Specified dose on specified days
Experimental: Part 2 cohort 2 Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.	Drug: Cadonilimab IV infusion,Specified dose on specified days Drug: AK117 IV infusion,Specified dose on specified days Drug: Oxaliplatin IV infusion,Specified dose on specified days Drug: Docetaxel IV infusion,Specified dose on specified days Drug: 5-Fluorouracil IV infusion,Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance [Up to approximately 2 years]
Pathological complete response (pCR) rates [Up to approximately 2 years]
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 [Up to approximately 2 years]
MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes
Tumor regression grade(TRG) [Up to approximately 2 years]
R0 resection rate [Up to approximately 2 years]
Tumor descending stage rate [Up to approximately 2 years]
Proportion of subjects whose tumor TNM stage decreased from baseline before surgery
ORR [Up to approximately 2 years]
EFS [Up to approximately 2 years]
OS [Up to approximately 2 years]
PK [Up to approximately 2 years]
Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points
ADA [Up to approximately 2 years]
Number of subjects with detectable anti-drug antibodies (ADA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.