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

Jiangxi Kvvit Pharmaceutical Co., Ltd.

Status and phase: Not yet enrolling; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Chemotherapy; Drug: DN022150

Study type: Interventional

Funder types: Industry

Identifiers

NCT07689539

DN022150-302

Details and patient eligibility

About

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

Full 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

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily signed informed consent form
2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent
3. Life expectancy ≥ 12 weeks
4. Subjects with confirmed KRAS G12D who have received prior systemic therapy for advanced or metastatic pancreatic cancer
5. ECOG score of performance status 0 ~ 1
6. At least one measurable lesion by RECIST v1.1 criteria
7. Adequate organ function
8. Effective methods of contraception during the study

Exclusion criteria

1. Progression or other malignancy requiring treatment within 5 years prior to enrollment
2. Prior targeted therapy for KRAS G12D
3. With central nervous system metastasis
4. Uncontrolled fluid accumulation
5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment
6. Concomitant clinically significant cardiovascular disease
7. Concurrent major acute or chronic infectious disease
8. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;
9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse
10. Other situations not suitable for the study judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

DN022150

Experimental group

Description:

iv, QW, 28day/cycle

Treatment:

Drug: DN022150

Chemotherapy

Active Comparator group

Description:

nal-IRI+5-FU/LV，AG or S-1

Treatment:

Drug: Chemotherapy