Health TrialsbyHealthPanel

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

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DN022150

    Drug

    iv QW 28-day/cycle

  • Chemotherapy

    Drug

    Investigator's Choice of Chemotherapy: nal-IRI + 5-FU/LV, AG, or S-1

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: DN022150Experimental treatment 1 intervention
Group B: ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Evaluated by Blinded Independent Central Review (BIRC)

Time frame
up to 2 years
2

Overall Survival (OS)

Time frame
up to 2 years

Secondary outcomes

1

Progression-Free Survival (PFS)

Evaluated by Investigator

Time frame
up to 2 years
2

Objective Response Rate (ORR)

Time frame
up to 2 years
3

Duration of Response (DoR)

Time frame
up to 2 years
4

Disease Control Rates (DCR)

Time frame
up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangxi Kvvit Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: