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Not yet recruiting NCT07689539

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

Phase III Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DN022150, Chemotherapy.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation

Overview

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

Detailed description

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

Interventions

  • Drug DN022150
    iv QW 28-day/cycle
  • Drug Chemotherapy
    Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: up to 2 years]
  • Overall Survival (OS) [Time frame: up to 2 years]
Secondary outcome measures (12)
  • Progression-Free Survival (PFS) [Time frame: up to 2 years]
  • Objective Response Rate (ORR) [Time frame: up to 2 years]
  • Duration of Response (DoR) [Time frame: up to 2 years]
  • Disease Control Rates (DCR) [Time frame: up to 2 years]
  • Time to Response (TTR） [Time frame: up to 2 years]
  • Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0 [Time frame: up to 2 years]
  • AUC0-t [Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）]
  • AUC0-inf [Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）]
  • Cmax [Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）]
  • Cmin [Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）]
  • t1/2 [Time frame: Cycle2Day1 Cycle4Day1 Cycle8Day1 （28day/cycle）]
  • EORTC QLQ-C30（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire） [Time frame: up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07689539 · DN022150-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗