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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104(SC)+XELOX | Experimental | AK104 SC plus XELOX |
|
| AK104(IV)+XELOX | Active Comparator | AK104 IV plus XELOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104(SC) | Drug | AK104:subcutaneous injection |
| |
| AK104(IV) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu | Contact | +86 (0760) 8987 3999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| Drug |
AK104:intravenous |
|
| Capecitabine | Drug | oral |
|
| Oxaliplatin injection | Drug | intravenous |
|
| 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. | 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 |
| 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 |
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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