Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

November 22, 2024 updated by: Shandong Suncadia Medicine Co., Ltd.

A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Quchang Ouyang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Females aged 18-75 years old (both ends inclusive);
  2. ECOG performance status (PS) 0-1 points;
  3. Patients with metastatic or locally advanced breast cancer confirmed by histology（ER positive, HER2 positive/negative，or triple negative breast cancer）.
  4. Tumor tissue samples must be provided for detection of tumor markers;
  5. Menopausal state;
  6. Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;
  7. There must be at least one measurable extracranial lesion that complies with RECIST v1.1;
  8. Expected survival >3 months;
  9. Good functional level of the organs ;
  10. Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the patient must be non-lactating;
  11. Voluntarily participate in this clinical trial, be willing and able to comply with clinical visits and research-related procedures, understand the research procedures and have signed informed consent.

Exclusion Criteria:

  1. Patients with active (without medical control or clinical symptoms) brain metastasis;
  2. Have the following lung diseases or history;
  3. History of clinically severe cardiovascular disease;
  4. Those who have received immunosuppressants or systemic hormone therapy for immunosuppression within 2 weeks before the first dose (dose >10 mg/d prednisone or other corticosteroids at equivalent physiological doses), excluding nasal spray or inhaled hormones;
  5. The damage caused by the subject receiving other treatments has not recovered (severity level NCI-CTCAE V5.0 classification ≤1, excluding hair loss and other adverse events judged to be tolerable by the researcher);
  6. There are serious infections within 4 weeks before the first medication;
  7. Untreated active hepatitis;
  8. The subject has suffered from other malignant tumors in the past 5 years or currently, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma;
  9. Presence of active autoimmune disease;
  10. Have a history of immunodeficiency, including acquired (HIV infection), congenital immunodeficiency diseases, or a history of organ transplantation (including allogeneic bone marrow transplantation);
  11. The subject is in the acute infection stage or active tuberculosis and requires drug treatment;
  12. Known to be allergic to the components of HRS-8080, SHR-A1811 and its components, SHR-A2009 and its components, and Adebrelimab; have a history of severe allergic reactions to other monoclonal antibodies;
  13. Patients who have other serious physical or mental illnesses or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who the researcher believes are not suitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A
Drug: HRS-8080; SHR-A1811
Participants will receive HRS-8080 and SHR-A1811
Experimental: Part B
Drug: HRS-8080; SHR-A2009
Participants will receive HRS-8080 and SHR-A2009
Experimental: Part C
Drug: SHR-A2009; SHR-1316
Participants will receive SHR-A2009 and SHR-1316

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limited Toxicity（DLT）
Time Frame: up to 1 cycle (21 days)
Phase 1
up to 1 cycle (21 days)
Maximum Tolerable Dose（MTD）
Time Frame: up to 1 cycle (21 days)
Phase 1
up to 1 cycle (21 days)
Recommended Phase 2 Dose（RP2D）
Time Frame: up to 1 cycle (21 days)
Phase 1
up to 1 cycle (21 days)
Safety endpoints: the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (rated based on CTCAE V5.0)
Time Frame: up to 12 months
Phase 1
up to 12 months
Efficacy endpoint: objective response rate (ORR)
Time Frame: up to 12 months
Phase 2
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
level of SHR-A1811 ADA and Nab
Time Frame: up to 12 months
Phase 1
up to 12 months
level of SHR-A2009 ADA and Nab
Time Frame: up to 12 months
Phase 1
up to 12 months
level of adebrelimab ADA and Nab
Time Frame: up to 12 months
Phase 1
up to 12 months
Objective response rate (ORR)
Time Frame: up to 12 months
Phase 1
up to 12 months
Best overall response (BOR)
Time Frame: up to 12 months
Phase 1
up to 12 months
Duration of response (DoR)
Time Frame: up to 12 months
Phase 1
up to 12 months
Disease control rate (DCR)
Time Frame: up to 12 months
Phase 1
up to 12 months
Clinical benefit rate (CBR)
Time Frame: up to 12 months
Phase 1
up to 12 months
Progression-free survival (PFS)
Time Frame: up to 12 months
Phase 1
up to 12 months
Safety endpoints: incidence and severity of AEs and SAEs (rated based on CTCAE V5.0)
Time Frame: up to 12 months
Phase 2
up to 12 months
level of SHR-A1811 ADA and Nab
Time Frame: up to 12 months
Phase 2
up to 12 months
level of SHR-A2009 ADA and Nab
Time Frame: up to 12 months
Phase 2
up to 12 months
level of adebrelimab ADA and Nab
Time Frame: up to 12 months
Phase 2
up to 12 months
Best overall response (BOR)
Time Frame: up to 12 months
Phase 2
up to 12 months
Duration of response (DoR)
Time Frame: up to 12 months
Phase 2
up to 12 months
Disease control rate (DCR)
Time Frame: up to 12 months
Phase 2
up to 12 months
Clinical benefit rate (CBR)
Time Frame: up to 12 months
Phase 2
up to 12 months
Progression-free survival (PFS)
Time Frame: up to 12 months
Phase 2
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-8080-202

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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