Pancreatic Cancer, Pancreatic Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGDN022150+AG( Stage I ）
28-day /cycle
DRUGDN022150+AG（Stage II）
28-day /cycle
DRUGplacebo+AG（Stage II）
28-day /cycle
Sponsors
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 not received prior systemic antineoplastic 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. 4\. 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 |
|---|---|---|
| DLT | up to 2 years | 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 |
| PFS as assessed by BICR per RECIST 1.1 | up to 2 years | stage II |
| OS | up to 2 years | stage II |
| ORR | up to 2 years | stage I |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0 | up to 2 years | stage I\&II |
| DOR as assessed by the investigator per RECIST v1.1 | up to 2 years | stage I |
| Cmin, ss | up to 2 year | stage I\&II: Steady State Trough Concentration |
| Pancreatic cancer quality of life specific scale | up to 2 years | stage II |
| DCR as assessed by the investigator per RECIST v1.1 | up to 2 years | stage I |
| PFS assessed by the investigator per RECIST v1.1 | up to 2 years | stage I |
| OS | up to 2 years | stage I |
| PFS as assessed by the investigator per RECIST v1.1 | up to 2 years | stage II |
| ORR as assessed by the investigator or BICR per RECIST v1.1 | up to 2 years | stage II |
| DOR as assessed by the investigator or BICR per RECIST v1.1 | up to 2 years | stage II |
| DCR as assessed by the investigator or BICR per RECIST v1.1 | up to 2 years | stage II |
| Cmax，ss | up to 2years | Maximum Steady-State Plasma Concentration |
| AUC0-t | up to 2years | stage I\&II AUC from time 0 to last measurable time |
| t1/2 | up to 2years | stageI\&II Half-life |
Contacts
CONTACTMan Xu
Outcome results
None listed