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Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib#Dosage regimen 1# | Experimental | Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression |
|
| Phase Ib#Dosage regimen 2# | Experimental | Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression |
|
| Phase II#Cohort 1# | Experimental | Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression |
|
| Phase II#Cohort 2# | Experimental | Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression |
|
| Phase II#Cohort 3# | Experimental | Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | IV infusion,Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events (AEs) | Up to approximately 2 years | |
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Up to approximately 2 years | |
| Duration of Response (DoR) | Up to approximately 2 years | |
| Time to response (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liwei Wang, MD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Renji Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D000077146 | Irinotecan |
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| AK117 | Drug | IV infusion,Specified dose on specified days |
|
| Capecitabine tablets | Drug | Oral,Specified dose on specified days |
|
| Oxaliplatin | Drug | IV infusion,Specified dose on specified days |
|
| Cisplatin | Drug | IV infusion,Specified dose on specified days |
|
| Paclitaxel | Drug | IV infusion,Specified dose on specified days |
|
| Irinotecan | Drug | IV infusion,Specified dose on specified days |
|
| Docetaxel | Drug | IV infusion,Specified dose on specified days |
|
| 5-FU | Drug | IV infusion,Specified dose on specified days |
|
| Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years |
| Maximum observed concentration (Cmax) of AK117 and AK104 | The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration. | From first dose of study drug to last dose of of study drug |
| Minimum observed concentration (Cmin) of AK117 and AK104 at steady state | The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration. | From first dose of study drug to last dose of of study drug |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | From first dose of study drug through 30 days after last dose of study drug |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |