A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

A Randomized, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric / Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: Capecitabine; Drug: AK104(SC); Drug: Oxaliplatin injection; Drug: AK104(IV)

• Study Type: Interventional
• Enrollment (Estimated): 422
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ting Liu; Phone Number: +86 (0760) 8987 3999; Email: clinicaltrials@akesobio.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
2. Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
3. Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
4. Adequate organ and bone marrow function.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
6. Measurable disease by RECIST 1.1.

Exclusion Criteria:

1. Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.
2. Deep venous thrombosis within 3 months before first treatment.
3. Uncontrolled arterial hypertension.
4. Bleeding events within the last 1 months.
5. Prior treatment with immune checkpoint inhibitors.
6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK104(SC)+XELOX; AK104 SC plus XELOX	Drug: Capecitabine; oral; Drug: AK104(SC); AK104:subcutaneous injection; Drug: Oxaliplatin injection; intravenous
Active Comparator: AK104(IV)+XELOX; AK104 IV plus XELOX	Drug: Capecitabine; oral; Drug: Oxaliplatin injection; intravenous; Drug: AK104(IV); AK104:intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).	Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).	up to 4 weeks
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.	Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) assessed by investigator per RECIST v1.1	PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.	Up to 24 months
Duration of Response (DOR) assessed by investigator per RECIST v1.1	DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.	Up to 24 months
Time to Response (TTR) assessed by investigator per RECIST v1.1	TTR refers to Time to Response.	Up to 24 months
Objective Response Rate (ORR) per RECIST 1.1	Assessed by investigators	up to 24 months
Disease Control Rate (DCR) per RECIST 1.1	Assessed by investigators	Up to 24 months
Overall Survival	OS is defined as the time from randomization to death due to any cause.	Up to 24 months
Number of participants with adverse event (AE)	The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.	Up to 27 months

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Principal Investigator: Yanqiao Zhang, The Second Affiliated Hospital of Harbin Medical University; Principal Investigator: Tao Zhang, UNIVERSITY OF SCIENCE AND TECHNOLOGY UNION HOSPITAL TONG JI MEDICAL COLLEGE HUA ZHONG

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): November 17, 2027
• Study Completion (Estimated): February 15, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Oxaliplatin
• Other Study ID Numbers: AK104-SC-01

Drug and device information, study documents

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