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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • DN022150+AG( Stage I )
  • DN022150+AG(Stage II)
  • placebo+AG(Stage II)

Treatment groups

465 Participants
are divided into 3 treatment groups

Locations

This trial has no locations