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This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib) | Experimental | Cadonilimab will be administered at a selected dose every 4 weeks (q4w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. |
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| Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib) | Experimental | Cadonilimab will be administered at a selected dose every 2 weeks (q2w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. |
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| Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II) | Experimental | Cadonilimab will be administered at a selected dose and frequency from phase Ib. AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. |
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| AK112 + nab-paclitaxel + gemcitabine(phase II) | Experimental | AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112, Cadonilimab, nab-paclitaxel, gemcitabine | Drug | IV infusion, specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) and serious adverse events (SAEs) | Frequency of AEs and SAEs for all Arms in phase Ib. | 28days+28days |
| Overall Response Rate (ORR) | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time | Up to Cycle 12 |
| Anti-Drug Antibodies(ADAs) | Number and percentage of patients with detectable anti-drug antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. | Wuhan | Hubei | China |
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| nab-paclitaxel + gemcitabine(phase II) | Active Comparator | Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. |
|
| AK112, Cadonilimab, nab-paclitaxel, gemcitabine | Drug | IV infusion, specified dose on specified days. |
|
| AK112, Cadonilimab, nab-paclitaxel, gemcitabine | Drug | IV infusion, specified dose on specified days. |
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| AK112, nab-paclitaxel, gemcitabine | Drug | IV infusion, specified dose on specified days. |
|
| nab-paclitaxel, gemcitabine | Drug | IV infusion, specified dose on specified days. |
|
| Up to approximately 2 years |
| Progression-Free Survival (PFS) | Evaluation of PFS based on RECIST v1.1. | Up to approximately 2 years |
| Overall survival (OS) | Evaluation of OS based on RECIST v1.1. | Up to approximately 2 years |
| Disease control rate (DCR) | Evaluation of DCR based on RECIST v1.1. | Up to approximately 2 years |
| Duration of Response (DoR) | Evaluation of DoR based on RECIST v1.1. | Up to approximately 2 years |
| Time to Response (TTR) | Evaluation of TTR based on RECIST v1.1. | Up to approximately 2 years |
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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