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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: AK117; Drug: Oxaliplatin; Drug: Docetaxel; Drug: 5-Fluorouracil; Drug: Cadonilimab; Drug: Tegafur-gimeracil-oteracil potassium

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weifeng Song, MD; Phone Number: +86(0760)89873999; Email: clinicaltrials@akesobio.com
• Study Contact Backup: Name: Han Liang, MD

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Provincial Tumor Hospital
    • Contact: Han Liang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 cohort 1; Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.	Drug: Oxaliplatin; IV infusion,Specified dose on specified days; Drug: Cadonilimab; 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: AK117; IV infusion,Specified dose on specified days; Drug: Oxaliplatin; IV infusion,Specified dose on specified days; Drug: Cadonilimab; 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: 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; Drug: Cadonilimab; 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: 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; Drug: Cadonilimab; IV infusion,Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADA	Number of subjects with detectable anti-drug antibodies (ADA).	Up to approximately 2 years
Major pathological response(MPR) rates	MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes	Up to approximately 2 years
Tumor regression grade(TRG)		Up to approximately 2 years
R0 resection rate		Up to approximately 2 years
Tumor descending stage rate	Proportion of subjects whose tumor TNM stage decreased from baseline before surgery	Up to approximately 2 years
ORR		Up to approximately 2 years
EFS		Up to approximately 2 years
OS		Up to approximately 2 years
PK	Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Fluorouracil; Oxaliplatin; Tegafur
• Other Study ID Numbers: AK104-219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No