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

NCT07689539 | Not Yet Recruiting Phase 3

• 1 other identifier: DN022150-302
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  Evaluated by Blinded Independent Central Review (BIRC)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Secondary Outcomes (13)

• Progression-Free Survival (PFS)

  up to 2 years

• 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

Study Arms (2)

DN022150

EXPERIMENTAL

iv, QW, 28day/cycle

Drug: DN022150

Chemotherapy

ACTIVE COMPARATOR

nal-IRI+5-FU/LV，AG or S-1

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

Chemotherapy

DN022150 DRUG

iv QW 28-day/cycle

DN022150

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 received prior systemic 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

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xu Man

CONTACT

+86 19979703650; xuman@kvvit.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share