An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent was obtained from all participants before participating in the study.

Age from 18 to 75 years old (including both ends), regardless of gender;

Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology;

Participants had received at least one previous systemic therapy

Disqualifiers

Presence of untreated or active central nervous system (CNS) metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or spinal cord compression.

Subjects who had received general anesthesia

Subjects with a history of myocardial infarction or unstable angina pectoris

Subjects with atrioventricular block or cardiac insufficiency

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-7058

    Drug

    HRS-7058

Treatment groups

92 Participants
are divided into 1 treatment group
Group A: Treatment group A: HRS-7058Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR as assessed by IRC

IRC evaluation

Time frame
About 2 years

Secondary outcomes

1

Investigator-assessed ORR

Assessments BY INVESTIGATORS

Time frame
About 2 years
2

IRC and investigator-assessed DoR

IRC and investigator assessments

Time frame
About 2 years
3

IRC and investigator-assessed DCR

IRC and investigator assessments

Time frame
About 2 years
4

IRC and investigator-assessed PFS

IRC and investigator assessments

Time frame
About 2 years

Other outcomes

Sponsors and contacts

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