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This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab in combination with pulocimab and paclitaxel | Experimental | Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks |
|
| Placebo in combination with paclitaxel | Active Comparator | Placebo in combination with Paclitaxel, iv, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cadonilimab | Drug | iv, q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by blinded independent central review (BICR) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria). | Up to 2 years |
| Overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria). | Up to 2 years |
| Objective Response Rate (ORR) |
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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 |
|---|---|---|
| Lin Shen, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Xiaotian Zhang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| pulocimab | Drug | iv, q3w |
|
|
| paclitaxel | Drug | iv, q3w |
|
| placebo | Drug | iv, q3w |
|
ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria |
| Up to 2 years |
| Duration of Response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first. | Up to 2 years |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria). | Up to 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |