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Not yet recruiting NCT07656376

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

Phase II / Phase III Interventional Pancreatic Cancer Pancreatic Carcinoma

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+AG( Stage I ）, DN022150+AG（Stage II）, placebo+AG（Stage II）.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Pancreatic Carcinoma. 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 →

Overview

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.

Interventions

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

Primary outcome measures

  • DLT [Time frame: up to 2 years]
  • PFS as assessed by BICR per RECIST 1.1 [Time frame: up to 2 years]
  • OS [Time frame: up to 2 years]
  • ORR [Time frame: up to 2 years]
Secondary outcome measures (12)
  • Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v6.0 [Time frame: up to 2 years]
  • DOR as assessed by the investigator per RECIST v1.1 [Time frame: up to 2 years]
  • Cmin, ss [Time frame: up to 2 year]
  • Pancreatic cancer quality of life specific scale [Time frame: up to 2 years]
  • DCR as assessed by the investigator per RECIST v1.1 [Time frame: up to 2 years]
  • PFS assessed by the investigator per RECIST v1.1 [Time frame: up to 2 years]
  • OS [Time frame: up to 2 years]
  • PFS as assessed by the investigator per RECIST v1.1 [Time frame: up to 2 years]
  • ORR as assessed by the investigator or BICR per RECIST v1.1 [Time frame: up to 2 years]
  • DOR as assessed by the investigator or BICR per RECIST v1.1 [Time frame: up to 2 years]
  • DCR as assessed by the investigator or BICR per RECIST v1.1 [Time frame: up to 2 years]
  • Cmax，ss [Time frame: up to 2years]

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 not received prior systemic antineoplastic 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
  • 4\. 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
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07656376 · DN022150-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗