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This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DN022150 | Experimental | iv, QW, 28day/cycle |
|
| Chemotherapy | Active Comparator | nal-IRI+5-FU/LV,AG or S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DN022150 | Drug | iv QW 28-day/cycle |
| |
| Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Evaluated by Blinded Independent Central Review (BIRC) | up to 2 years |
| Overall Survival (OS) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Evaluated by Investigator | up to 2 years |
| Objective Response Rate (ORR) | up to 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Man | Contact | +86 19979703650 | xuman@kvvit.com |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Drug |
Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1 |
|
| Duration of Response (DoR) |
| up to 2 years |
| Disease Control Rates (DCR) | up to 2 years |
| Time to Response (TTR) | up to 2 years |
| Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0 | up to 2 years |
| AUC0-t | Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle) |
| AUC0-inf | Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle) |
| Cmax | Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle) |
| Cmin | Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle) |
| t1/2 | Cycle2Day1 Cycle4Day1 Cycle8Day1 (28day/cycle) |
| EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) | scale 0-100,higher scores mean a worse outcome | up to 2 years |
| EORTC QLQ-PAN26(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26) | scale 0-100,higher scores mean a worse outcome | up to 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |