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

NCT05960955 | Recruiting Phase 2

• 1 other identifier: AK104-219
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Major pathological response(MPR) rates

  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

  Up to approximately 2 years

• ORR

  Up to approximately 2 years

Study Arms (4)

Part 1 cohort 1

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Tegafur-gimeracil-oteracil potassium

Part 1 cohort 2

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: AK117; Drug: Oxaliplatin; Drug: Tegafur-gimeracil-oteracil potassium

Part 2 cohort 1

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Docetaxel; Drug: 5-Fluorouracil

Part 2 cohort 2

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: AK117; Drug: Oxaliplatin; Drug: Docetaxel; Drug: 5-Fluorouracil

Interventions

Cadonilimab DRUG

IV infusion,Specified dose on specified days

Part 1 cohort 1; Part 1 cohort 2; Part 2 cohort 1; Part 2 cohort 2

AK117 DRUG

IV infusion,Specified dose on specified days

Part 1 cohort 2; Part 2 cohort 2

Oxaliplatin DRUG

IV infusion,Specified dose on specified days

Part 1 cohort 1; Part 1 cohort 2; Part 2 cohort 1; Part 2 cohort 2

Tegafur-gimeracil-oteracil potassium DRUG

Oral,Specified dose on specified days

Part 1 cohort 1; Part 1 cohort 2

Docetaxel DRUG

IV infusion,Specified dose on specified days

Part 2 cohort 1; Part 2 cohort 2

5-Fluorouracil DRUG

IV infusion,Specified dose on specified days

Part 2 cohort 1; Part 2 cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able and willing to provide written informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Tianjin Provincial Tumor Hospital

Tianjin, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Docetaxel; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Weifeng Song, MD

CONTACT

+86(0760)89873999; clinicaltrials@akesobio.com

Han Liang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: November 13, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)