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

Sponsor
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study ID
NCT07689539
Phase
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 — DRUG
    iv QW 28-day/cycle
  • Chemotherapy — DRUG
    Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

Study Details

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

Key Dates

First listed
Jul 8, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: DN022150
    iv, QW, 28day/cycle
  • Active Comparator: Chemotherapy
    nal-IRI+5-FU/LV，AG or S-1

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: up to 2 years ]

Central Contacts

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