An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer
An Open, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-7058 in Patients With Locally Advanced or Metastatic Pancreatic Cancer Harboring KRAS G12C Mutations Who Have Failed Prior Systemic Therapy.
1 other identifier
interventional
92
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started May 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 9, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 15, 2026
May 1, 2026
2.6 years
May 9, 2026
May 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
ORR as assessed by IRC
IRC evaluation
About 2 years
Secondary Outcomes (5)
Investigator-assessed ORR
About 2 years
IRC and investigator-assessed DoR
About 2 years
IRC and investigator-assessed DCR
About 2 years
IRC and investigator-assessed PFS
About 2 years
OS
About 4 years
Study Arms (1)
Treatment group A: HRS-7058
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- At least one measurable lesion according to RECIST v1.1;
- ECOG PS score 0 or 1;
- The expected survival time was more than 3 months.
- They were able to swallow medications and were able to adhere to trial and follow-up procedures.
- Adequate bone marrow and organ function within 7 days before the first dose (no use of blood components and/or cell growth factors within 14 days before starting study treatment;
- Women of childbearing potential had to agree to abstain from sexual intercourse (heterosexual intercourse) or to use a highly effective method of contraception from the time they provided informed consent until 30 days after the last dose of the trial drug. A blood test for human chorionic gonadotropin (HCG) had to be negative within 7 days before starting study treatment and she had to be nonlactating (if a serum pregnancy test was positive, pregnancy was ruled out and enrollment was confirmed after discussion with the sponsor). Men whose partner was a woman of childbearing potential had to agree to abstain from sex or to use a highly effective method of contraception from the time they provided written informed consent until 30 days after the last dose of the trial drug. Male patients also had to agree not to donate sperm during the same period
You may not qualify if:
- 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
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
- Subjects with abnormal clotting function
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with a history or possibility of a difficult airway
- Subject with a history of substance abuse and drug abuse
- Adrenoceptor agonists or antagonists were used before randomization
- Abnormal values in the laboratory
- Thyroid dysfunction
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jiangsu Province Hospital
Nanjing, Jiangsu, 210003, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2026
First Posted
May 15, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 15, 2026
Record last verified: 2026-05