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
1 other identifier
interventional
146
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Typical duration for phase_1
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
First Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
December 12, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
January 9, 2026
January 1, 2026
2.4 years
December 4, 2023
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Treatment group A
EXPERIMENTALInterventions
HRS-8080 combined with Dalpiciclib Isethionate Tablets
Eligibility Criteria
You may qualify if:
- Women aged 18-75 years with both ends included.
- ECOG Physical status 0-1 points.
- Patients with histologically confirmed metastatic or locally advanced breast cancer.
- 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.
- Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression.
- At least one measurable extracranial lesion must be present.
- Expected survival \>3 months.
- The functional level of the organ must meet the requirements of the test.
- 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.
- 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.
You may not qualify if:
- Symptoms of visceral metastasis.
- Previous treatment did not meet trial requirements.
- 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.
- 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.
- 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.
- A history of clinically severe cardiovascular disease.
- Patients with uncontrolled tumor-related pain as judged by the investigator.
- Those who received immunosuppressive agents or systemic hormone therapy for immunosuppression within 2 weeks prior to the first dose.
- The damage caused by the subject receiving other treatments has been recovered.
- Severe infection occurred within 4 weeks prior to the second dose.
- The first study investigated the occurrence of arteriovenous thrombosis within 6 months prior to medication.
- Patients with clinically significant endometrial abnormalities.
- Untreated active hepatitis.
- Subjects had other malignancies within the past 5 years or currently.
- Have an inherited or acquired bleeding tendency.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, 100000, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2023
First Posted
December 12, 2023
Study Start
December 20, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01