Pancreatic Cancer
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGDN022150
iv QW 28-day/cycle
DRUGChemotherapy
Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1
Sponsors
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed informed consent form 2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent 3. Life expectancy ≥ 12 weeks 4. Subjects with confirmed KRAS G12D who have received prior systemic therapy for advanced or metastatic pancreatic cancer 5. ECOG score of performance status 0 \~ 1 6. At least one measurable lesion by RECIST v1.1 criteria 7. Adequate organ function 8. Effective methods of contraception during the study
Exclusion criteria
1. Progression or other malignancy requiring treatment within 5 years prior to enrollment 2. Prior targeted therapy for KRAS G12D 3. With central nervous system metastasis 4. Uncontrolled fluid accumulation 5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment 6. Concomitant clinically significant cardiovascular disease 7. Concurrent major acute or chronic infectious disease 8. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study; 9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse 10. Other situations not suitable for the study judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | up to 2 years | Evaluated by Blinded Independent Central Review (BIRC) |
| Overall Survival (OS) | up to 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | up to 2 years | Evaluated by Investigator |
| Objective Response Rate (ORR) | up to 2 years | — |
| 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） | up to 2 years | scale 0-100，higher scores mean a worse outcome |
| EORTC QLQ-PAN26（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer 26） | up to 2 years | scale 0-100，higher scores mean a worse outcome |
Contacts
CONTACTXu Man
Outcome results
None listed