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

NCT07656376 | Not Yet Recruiting Phase 2

• 1 other identifier: DN022150-301
• Study Type: interventional
• Target: 465
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer; Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0

  up to 2 years

• DOR as assessed by the investigator per RECIST v1.1

  up to 2 years

• Cmin, ss

  up to 2 year

• Pancreatic cancer quality of life specific scale

  up to 2 years

• DCR as assessed by the investigator per RECIST v1.1

  up to 2 years

Study Arms (3)

DN022150+AG( Stage I ）

EXPERIMENTAL

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 ）

DN022150+AG（ Stage II）

EXPERIMENTAL

Stage II DN022150（ RP3D)+AG

Drug: DN022150+AG（Stage II）

DN022150 placebo+AG（ Stage II）

PLACEBO COMPARATOR

Stage II DN022150 placebo+AG

Drug: placebo+AG（Stage II）

Interventions

DN022150+AG( Stage I ） DRUG

28-day /cycle

Also known as: Dose-finding group

DN022150+AG( Stage I ）

DN022150+AG（Stage II） DRUG

28-day /cycle

Also known as: Test group

DN022150+AG（ Stage II）

placebo+AG（Stage II） DRUG

28-day /cycle

Also known as: Control group

DN022150 placebo+AG（ Stage II）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent form
• Age 18-75 years (inclusive), male or female, at the time of signing informed consent
• Life expectancy ≥ 12 weeks
• Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer
• ECOG score of performance status 0 \~ 1
• At least one measurable lesion by RECIST v1.1 criteria
• Adequate organ function
• Effective methods of contraception during the study

You may not qualify if:

• Progression or other malignancy requiring treatment within 5 years prior to enrollment
• Prior targeted therapy for KRAS G12D
• With central nervous system metastasis
• Uncontrolled fluid accumulation
• Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
• Concomitant clinically significant cardiovascular disease
• Concurrent major acute or chronic infectious disease
• \. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
• History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
• Other situations not suitable for the study judged by the investigator

Sponsors & Collaborators

• Jiangxi Kvvit Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Man Xu

CONTACT

+86 19979703650; xuman@kvvit.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): June 6, 2027
• Primary Completion (Estimated): February 7, 2029
• Study Completion (Estimated): May 8, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share