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
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 422
- Primary Endpoint
- Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
AK104(SC)+XELOX
AK104 SC plus XELOX
Intervention: AK104(SC) (Drug)
AK104(SC)+XELOX
AK104 SC plus XELOX
Intervention: Capecitabine (Drug)
AK104(SC)+XELOX
AK104 SC plus XELOX
Intervention: Oxaliplatin injection (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
Intervention: AK104(IV) (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
Intervention: Capecitabine (Drug)
AK104(IV)+XELOX
AK104 IV plus XELOX
Intervention: Oxaliplatin injection (Drug)
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 serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
Time Frame: up to 4 weeks
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
Secondary Outcomes
- Disease Control Rate (DCR) per RECIST 1.1(Up to 24 months)
- Objective Response Rate (ORR) 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)
- Overall Survival(Up to 24 months)
- Number of participants with adverse event (AE)(Up to 27 months)