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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: HRS-7058

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Keke Yan; Phone Number: +0518-81220121; Email: keke.yan@hengrui.com
• Study Contact Backup: Name: Meng Qin; Phone Number: +0518-81220121; Email: meng.qin.mq8@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • Recruiting
      • Jiangsu Province Hospital
      • Principal Investigator: Kuirong Jiang
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Principal Investigator: Jihui Hao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-7058	Drug: HRS-7058; HRS-7058

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR as assessed by IRC	IRC evaluation	About 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed ORR	Assessments BY INVESTIGATORS	About 2 years
IRC and investigator-assessed DoR	IRC and investigator assessments	About 2 years
IRC and investigator-assessed DCR	IRC and investigator assessments	About 2 years
IRC and investigator-assessed PFS	IRC and investigator assessments	About 2 years
OS	Assessments BY INVESTIGATORS	About 4 years

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: HRS-7058-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No