Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Pancreatic Carcinoma
• Intervention / Treatment: Drug: DN022150+AG( Stage I ）; Drug: DN022150+AG（Stage II）; Drug: placebo+AG（Stage II）

• Study Type: Interventional
• Enrollment (Estimated): 465
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Man Xu; 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DN022150+AG( Stage I ）; 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	Drug: DN022150+AG( Stage I ）; 28-day /cycle; Other Names: Dose-finding group
Experimental: DN022150+AG（ Stage II）; Stage II DN022150（ RP3D)+AG	Drug: DN022150+AG（Stage II）; 28-day /cycle; Other Names: Test group
Placebo Comparator: DN022150 placebo+AG（ Stage II）; Stage II DN022150 placebo+AG	Drug: placebo+AG（Stage II）; 28-day /cycle; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	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	up to 2 years
PFS as assessed by BICR per RECIST 1.1	stage II	up to 2 years
OS	stage II	up to 2 years
ORR	stage I	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0	stage I&II	up to 2 years
DOR as assessed by the investigator per RECIST v1.1	stage I	up to 2 years
Cmin, ss	stage I&II: Steady State Trough Concentration	up to 2 year
Pancreatic cancer quality of life specific scale	stage II	up to 2 years
DCR as assessed by the investigator per RECIST v1.1	stage I	up to 2 years
PFS assessed by the investigator per RECIST v1.1	stage I	up to 2 years
OS	stage I	up to 2 years
PFS as assessed by the investigator per RECIST v1.1	stage II	up to 2 years
ORR as assessed by the investigator or BICR per RECIST v1.1	stage II	up to 2 years
DOR as assessed by the investigator or BICR per RECIST v1.1	stage II	up to 2 years
DCR as assessed by the investigator or BICR per RECIST v1.1	stage II	up to 2 years
Cmax，ss	Maximum Steady-State Plasma Concentration	up to 2years
AUC0-t	stage I&II AUC from time 0 to last measurable time	up to 2years
t1/2	stageI&II Half-life	up to 2years

Collaborators and Investigators

• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 6, 2027
• Primary Completion (Estimated): February 7, 2029
• Study Completion (Estimated): May 8, 2029

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 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; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: DN022150-301

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