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

Sponsor
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study ID
NCT07656376
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DN022150+AG( Stage I ） — DRUG
    28-day /cycle
  • DN022150+AG（Stage II） — DRUG
    28-day /cycle
  • placebo+AG（Stage II） — DRUG
    28-day /cycle

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 6, 2027
Status verified
Jun 2026
Primary completion
Feb 7, 2029
Completion
May 8, 2029

Study Design

Enrollment
465 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: DN022150+AG（ Stage II）
    Stage II DN022150（ RP3D)+AG
  • Placebo Comparator: DN022150 placebo+AG（ Stage II）
    Stage II DN022150 placebo+AG

Primary Outcome Measure

DLT [ Time Frame: up to 2 years ]

Central Contacts

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