Clinical trial · Interventional
Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation
NCT07656376CI-TRIAL-00115288not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DN022150+AG( Stage I ) | Drug | — | UNRESOLVED |
| DN022150+AG(Stage II) | Drug | — | UNRESOLVED |
| placebo+AG(Stage II) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DN022150+AG( Stage I )
- description
- 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
- interventionNames
- Drug: DN022150+AG( Stage I )
- type
- EXPERIMENTAL
- label
- DN022150+AG( Stage II)
- description
- Stage II DN022150( RP3D)+AG
- interventionNames
- Drug: DN022150+AG(Stage II)
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.