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

Phase 3Not Yet RecruitingNCT07449780

Akeso422 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

422

Conditions

Gastric / Gastroesophageal Junction Adenocarcinoma

Interventions

AK104(SC)DRUG

AK104:subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).

Time frame: up to 4 weeks

Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.

Time frame: up to 4 weeks

Secondary Outcomes

Objective Response Rate (ORR) per RECIST 1.1

Assessed by investigators

Time frame: up to 24 months

Disease Control Rate (DCR) per RECIST 1.1

Assessed by investigators

Time frame: Up to 24 months

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.

Time frame: 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.

Time frame: Up to 24 months

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

TTR refers to Time to Response.

Time frame: Up to 24 months

Overall Survival

OS is defined as the time from randomization to death due to any cause.

Time frame: 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.

Time frame: Up to 27 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts