Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer

This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.

Study Overview

• Status: Recruiting
• Conditions: Unresectable or Metastatic Breast Cancer
• Intervention / Treatment: Drug: HRS-8080; Dalpiciclib Isethionate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Min Li; Phone Number: +0518-81220121; Email: min.li.ml150@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Chinese PLA General Hospital Fifth Medical Center
      • Contact: Zefei Jiang, Doctor; Phone Number: +86- 13901372170; Email: jiangzefei@csco.org.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center (SYSUCC)
      • Principal Investigator: Shusen Wang
      • Contact: Shusen Wang; Phone Number: +86-020-87343535; Email: wangshs@sysucc.org.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Women aged 18-75 years with both ends included.
2. ECOG Physical status 0-1 points.
3. Patients with histologically confirmed metastatic or locally advanced breast cancer.
4. Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past, efficacy extension stage: has not received any systemic treatment for advanced disease5.
5. Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression.
6. At least one measurable extracranial lesion must be present.
7. Expected survival >3 months.
8. The functional level of the organ must meet the requirements of the test.
9. Fertile female subjects must consent to use highly effective contraception during the study treatment period and for 7 months after the end of the study treatment period; Fertile female subjects must be negative for serum HCG within 7 days prior to study enrollment and must be non-lactating.
10. Volunteer to participate in this clinical trial, be willing and able to follow clinical visit and study related procedures, understand study procedures and have signed informed consent.

Exclusion Criteria:

1. Symptoms of visceral metastasis.
2. Previous treatment did not meet trial requirements.
3. Received nitrosourea or mitomycin within 6 weeks before the first dose in this study; Received major organ surgery, cytotoxic drugs, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical investigational drugs within 4 weeks before the first medication; He received endocrine therapy and palliative radiotherapy within 2 weeks before the first dose.
4. Less than 14 days after the first dose of CYP3A4; CYP3A4 is treated with a strong inducer <28 days from the date of first administration.
5. Patients with active (untreated or clinically symptomatic) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system.
6. A history of clinically severe cardiovascular disease.
7. Patients with uncontrolled tumor-related pain as judged by the investigator.
8. Those who received immunosuppressive agents or systemic hormone therapy for immunosuppression within 2 weeks prior to the first dose.
9. The damage caused by the subject receiving other treatments has been recovered.
10. Severe infection occurred within 4 weeks prior to the second dose.
11. The first study investigated the occurrence of arteriovenous thrombosis within 6 months prior to medication.
12. Patients with clinically significant endometrial abnormalities.
13. Untreated active hepatitis.
14. Subjects had other malignancies within the past 5 years or currently.
15. Have an inherited or acquired bleeding tendency.
16. History of active autoimmune disease, immune deficiency, and autoimmune disease.
17. One of the many factors that affect oral medications.
18. Subjects are acutely infected or have active TB and require medication.
19. Known allergy to HRS-8080 ingredient, Dalpiciclib and ingredient.
20. Pregnant and lactating women or women planning to become pregnant during the study period.
21. There is a clear history of neurological or psychiatric disorders and the subjects have a history of psychotropic substance abuse or drug use.
22. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.

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	Drug: HRS-8080; Dalpiciclib Isethionate Tablets; HRS-8080 combined with Dalpiciclib Isethionate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity (DLT)	About 2 years
Maximum tolerated dose (MTD)	About 2 years
Recommended phase II dose (RP2D)	About 2 years
Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	About 2 years
Outcome endpoint: Objective Response Rate (ORR)	About 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Steady-state peak concentration (Cmax,ss)	About 2 years
Steady-state peak time (Tmax,ss)	About 2 years
Steady-state valley concentration (Cmin,ss)	About 2 years
Steady-state blood drug concentration-time curve area (AUCss)	About 2 years
Best overall response (BOR)	About 2 years
Duration of response (DoR)	About 2 years
Disease control rate (DCR)	About 2 years
Clinical benefit rate (CBR)	About 2 years
Progression-free survival (PFS)	About 2 years

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HRS-8080-201

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