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This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine | Experimental |
| |
| Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Experimental |
| |
| Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine | Drug | Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response (OS) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 | PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | +86-18116403289 | wenting01.li@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | China |
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|
| Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine | Drug | Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest. |
|
| Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine | Drug | Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest. |
|
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1. |
| Up to approximately 2 years |
| Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Duration of response (DoR) assessed by the investigator per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Time to response (TTR) assessed by the investigator per RECIST v1.1 | Time to response (TTR) is defined as the time to response based on RECIST v1.1. | Up to approximately 2 years |
| Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. | Up to approximately 2 years |
| Cmax and Cmin | AK112 serum drug concentrations in subjects at different time points after AK112 administration. | Up to approximately 2 years |
| Anti-drug antibodies (ADA) | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 20032 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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