NCT07449780

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P50-P75 for phase_3

Timeline
20mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Gastric / Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Objective Response Rate (ORR) per RECIST 1.1

    up to 24 months

  • Disease Control Rate (DCR) per RECIST 1.1

    Up to 24 months

  • Progression-free survival (PFS) assessed by investigator per RECIST v1.1

    Up to 24 months

  • Duration of Response (DOR) assessed by investigator per RECIST v1.1

    Up to 24 months

  • Time to Response (TTR) assessed by investigator per RECIST v1.1

    Up to 24 months

  • +2 more secondary outcomes

Study Arms (2)

AK104(SC)+XELOX

EXPERIMENTAL

AK104 SC plus XELOX

Drug: AK104(SC)Drug: CapecitabineDrug: Oxaliplatin injection

AK104(IV)+XELOX

ACTIVE COMPARATOR

AK104 IV plus XELOX

Drug: AK104(IV)Drug: CapecitabineDrug: Oxaliplatin injection

Interventions

AK104(SC)DRUG

AK104:subcutaneous injection

AK104(SC)+XELOX
AK104(IV)DRUG

AK104:intravenous

AK104(IV)+XELOX
CapecitabineDRUG

oral

AK104(IV)+XELOXAK104(SC)+XELOX
Oxaliplatin injectionDRUG

intravenous

AK104(IV)+XELOXAK104(SC)+XELOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Deep venous thrombosis within 3 months before first treatment.
  • Uncontrolled arterial hypertension.
  • Bleeding events within the last 1 months.
  • Prior treatment with immune checkpoint inhibitors.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CapecitabineOxaliplatin

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu

CONTACT

+86 (0760) 8987 3999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

November 17, 2027

Study Completion (Estimated)

February 15, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02