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This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I :explores the combination dose and the second phase; Stage II :patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DN022150+AG( Stage I ) | Experimental | Stage I,To evaluate the safety and tolerability of two different doses of DN022150 for Injection combined with AG regimen preset, and to determine the recommended dose of DN022150 for Injection combined with AG regimen for efficacy expansion based on the PK and preliminary efficacy data. After the completion of efficacy expansion, the safety, tolerability, PK and preliminary efficacy data of the first phase will be synthesized to confirm the RP3D of DN022150 combined with AG regimen |
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| DN022150+AG( Stage II) | Experimental | Stage II DN022150( RP3D)+AG |
|
| DN022150 placebo+AG( Stage II) | Placebo Comparator | Stage II DN022150 placebo+AG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DN022150+AG( Stage I ) | Drug | 28-day /cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT | stage I :To evaluate the safety and tolerability of different doses of DN022150 for Injection combined with AG regimen in participants with locally advanced or metastatic pancreatic cancer, including the incidence of dose limiting toxicity (DLT), explore the MTD, and determine the RP3D of DN022150 for Injection combined with AG regimen in combination with PK and efficacy data | up to 2 years |
| PFS as assessed by BICR per RECIST 1.1 | stage II | up to 2 years |
| OS | stage II | up to 2 years |
| ORR | stage I | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0 | stage I&II | up to 2 years |
| DOR as assessed by the investigator per RECIST v1.1 | stage I |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man Xu | Contact | +86 19979703650 | xuman@kvvit.com |
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| DN022150+AG(Stage II) | Drug | 28-day /cycle |
|
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| placebo+AG(Stage II) | Drug | 28-day /cycle |
|
|
| up to 2 years |
| Cmin, ss | stage I&II: Steady State Trough Concentration | up to 2 year |
| Pancreatic cancer quality of life specific scale | stage II | up to 2 years |
| DCR as assessed by the investigator per RECIST v1.1 | stage I | up to 2 years |
| PFS assessed by the investigator per RECIST v1.1 | stage I | up to 2 years |
| OS | stage I | up to 2 years |
| PFS as assessed by the investigator per RECIST v1.1 | stage II | up to 2 years |
| ORR as assessed by the investigator or BICR per RECIST v1.1 | stage II | up to 2 years |
| DOR as assessed by the investigator or BICR per RECIST v1.1 | stage II | up to 2 years |
| DCR as assessed by the investigator or BICR per RECIST v1.1 | stage II | up to 2 years |
| Cmax,ss | Maximum Steady-State Plasma Concentration | up to 2years |
| AUC0-t | stage I&II AUC from time 0 to last measurable time | up to 2years |
| t1/2 | stageI&II Half-life | up to 2years |
| 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 |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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