NCT07589569 An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer
| NCT ID | NCT07589569 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2026-06-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Informed consent was obtained from all participants before participating in the study. 2. Age from 18 to 75 years old (including both ends), regardless of gender; 3. Patients with locally advanced unresectable, recurrent unresectable or metastatic pancreatic cancer, and adenocarcinoma confirmed by cytology or histological pathology; 4. Participants had received at least one previous systemic therapy 5. At least one measurable lesion according to RECIST v1.1; 6. ECOG PS score 0 or 1; 7. The expected survival time was more than 3 months. 8. They were able to swallow medications and were able to adhere to trial and follow-up procedures. 9. 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; 10. 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 Exclusion Criteria: 1. 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. 2. Subjects who had received general anesthesia 3. Subjects with a history of myocardial infarction or unstable angina pectoris 4. Subjects with atrioventricular block or cardiac insufficiency 5. Subjects with a history of ischemic stroke or transient ischemic attack 6. Subjects with poor blood pressure control after medication 7. Subjects with abnormal clotting function 8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy 9. Subjects with a history or possibility of a difficult airway 10. Subject with a history of substance abuse and drug abuse 11. Adrenoceptor agonists or antagonists were used before randomization 12. Abnormal values in the laboratory 13. Thyroid dysfunction 14. Allergic to a drug ingredient or component 15. Pregnant or nursing women 16. No birth control during the specified period of time 17. Participated in clinical trials of other drugs (received experimental drugs) 18. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07589569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07589569 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07589569 currently recruiting?
Yes, NCT07589569 is actively recruiting participants. Contact the research team at meng.qin.mq8@hengrui.com for enrollment information.
Where is the NCT07589569 trial being conducted?
This trial is being conducted at Nanjing, China, Tianjin, China.
Who is sponsoring the NCT07589569 clinical trial?
NCT07589569 is sponsored by Shandong Suncadia Medicine Co., Ltd.. The trial plans to enroll 92 participants.
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