Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation

NCT07689539 — Phase 3, Not yet recruiting, 360 participants, Jiangxi Kvvit Pharmaceutical Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation

Registry	NCT07689539
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	360 (Estimated)
Sponsor	Jiangxi Kvvit Pharmaceutical Co., Ltd. (Industry)
Conditions	Pancreatic Cancer
Interventions	DN022150, Chemotherapy (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2028-07-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-07-08, last updated 2026-07-08

-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

Expand all sections · Collapse all

+Detailed description

+Arms and interventions

Arm	Type	Interventions	Description
DN022150	Experimental	Drug: DN022150	iv, QW, 28day/cycle
Chemotherapy	Active comparator	Drug: Chemotherapy	nal-IRI+5-FU/LV，AG or S-1

DN022150 (Drug): iv QW 28-day/cycle
Chemotherapy (Drug): Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

+Outcome measures

Primary outcomes

Progression-Free Survival (PFS) [up to 2 years]: Evaluated by Blinded Independent Central Review (BIRC)
Overall Survival (OS) [up to 2 years]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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