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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

ConditionGastric / Gastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK104(SC)

    Drug

    AK104:subcutaneous injection

  • AK104(IV)

    Drug

    AK104:intravenous

  • Capecitabine

    Drug

    oral

  • Oxaliplatin injection

    Drug

    intravenous

Treatment groups

422 Participants
are divided into 2 treatment groups
Group A: AK104(SC)+XELOXExperimental treatment 3 interventions
Group B: AK104(IV)+XELOXActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 4 weeks
2

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.

Time frame
up to 4 weeks

Secondary outcomes

1

Objective Response Rate (ORR) per RECIST 1.1

Assessed by investigators

Time frame
up to 24 months
2

Disease Control Rate (DCR) per RECIST 1.1

Assessed by investigators

Time frame
Up to 24 months
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: