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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: DN022150; Drug: 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

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xu Man; Phone Number: +86 19979703650; Email: xuman@kvvit.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DN022150; iv, QW, 28day/cycle	Drug: DN022150; iv QW 28-day/cycle
Active Comparator: Chemotherapy; nal-IRI+5-FU/LV，AG or S-1	Drug: Chemotherapy; Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		up to 2 years
Progression-Free Survival (PFS)	Evaluated by Blinded Independent Central Review (BIRC)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)		up to 2 years
Progression-Free Survival (PFS)	Evaluated by Investigator	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）	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

Collaborators and Investigators

• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Therapeutics; Drug Therapy
• Other Study ID Numbers: DN022150-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No