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Breast CancerPhase 1/2NCT06222879

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

A Phase 1/2 study testing HRS-8080; SHR-A1811, HRS-8080; SHR-A2009 and SHR-A2009; SHR-1316 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
HRS-8080; SHR-A1811, HRS-8080; SHR-A2009 and SHR-A2009; SHR-1316
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
20 Feb 2024to 31 Oct 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females aged 18-75 years old (both ends inclusive);
  • ECOG performance status (PS) 0-1 points;
  • Patients with metastatic or locally advanced breast cancer confirmed by histology（ER positive, HER2 positive/negative，or triple negative breast cancer）.
  • Tumor tissue samples must be provided for detection of tumor markers;
  • Menopausal state;
  • Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;
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  • There must be at least one measurable extracranial lesion that complies with RECIST v1.1;
  • Expected survival >3 months;
  • Good functional level of the organs ;
  • 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;
  • 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.

Who cannot join

  • Patients with active (without medical control or clinical symptoms) brain metastasis;
  • Have the following lung diseases or history;
  • History of clinically severe cardiovascular disease;
  • 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;
  • 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);
  • There are serious infections within 4 weeks before the first medication;
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  • Untreated active hepatitis;
  • 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;
  • Presence of active autoimmune disease;
  • Have a history of immunodeficiency, including acquired (HIV infection), congenital immunodeficiency diseases, or a history of organ transplantation (including allogeneic bone marrow transplantation);
  • The subject is in the acute infection stage or active tuberculosis and requires drug treatment;
  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country.

Na An contact

+86 18500038119

na.an@hengrui.com

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Quchang Ouyang, 13973135318, oyqc1969@126.com

    Quchang Ouyang

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
HRS-8080; SHR-A1811, HRS-8080; SHR-A2009, SHR-A2009; SHR-1316
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-8080; SHR-A1811Drug

    Participants will receive HRS-8080 and SHR-A1811

  • HRS-8080; SHR-A2009Drug

    Participants will receive HRS-8080 and SHR-A2009

  • SHR-A2009; SHR-1316Drug

    Participants will receive SHR-A2009 and SHR-1316

Study groups in NCT06222879
Study groupRoleWhat they receive
Part AExperimentalNot described
Receives: Drug: HRS-8080; SHR-A1811
Part BExperimentalNot described
Receives: Drug: HRS-8080; SHR-A2009
Part CExperimentalNot described
Receives: Drug: SHR-A2009; SHR-1316

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limited Toxicity（DLT）

    Phase 1

    Measured: up to 1 cycle (21 days)

  2. Maximum Tolerable Dose（MTD）

    Phase 1

    Measured: up to 1 cycle (21 days)

  3. Recommended Phase 2 Dose（RP2D）

    Phase 1

    Measured: up to 1 cycle (21 days)

  4. Safety endpoints: the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (rated based on CTCAE V5.0)

    Phase 1

    Measured: up to 12 months

  5. Efficacy endpoint: objective response rate (ORR)

    Phase 2

    Measured: up to 12 months

Secondary outcomes (18)

  1. level of SHR-A1811 ADA and Nab

    Phase 1

    Measured: up to 12 months

  2. level of SHR-A2009 ADA and Nab

    Phase 1

    Measured: up to 12 months

  3. level of adebrelimab ADA and Nab

    Phase 1

    Measured: up to 12 months

  4. Objective response rate (ORR)

    Phase 1

    Measured: up to 12 months

  5. Best overall response (BOR)

    Phase 1

    Measured: up to 12 months

  6. Duration of response (DoR)

    Phase 1

    Measured: up to 12 months

  7. Disease control rate (DCR)

    Phase 1

    Measured: up to 12 months

  8. Clinical benefit rate (CBR)

    Phase 1

    Measured: up to 12 months

  9. Progression-free survival (PFS)

    Phase 1

    Measured: up to 12 months

  10. Safety endpoints: incidence and severity of AEs and SAEs (rated based on CTCAE V5.0)

    Phase 2

    Measured: up to 12 months

  11. level of SHR-A1811 ADA and Nab

    Phase 2

    Measured: up to 12 months

  12. level of SHR-A2009 ADA and Nab

    Phase 2

    Measured: up to 12 months

  13. level of adebrelimab ADA and Nab

    Phase 2

    Measured: up to 12 months

  14. Best overall response (BOR)

    Phase 2

    Measured: up to 12 months

  15. Duration of response (DoR)

    Phase 2

    Measured: up to 12 months

  16. Disease control rate (DCR)

    Phase 2

    Measured: up to 12 months

  17. Clinical benefit rate (CBR)

    Phase 2

    Measured: up to 12 months

  18. Progression-free survival (PFS)

    Phase 2

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start20 Feb 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three parallel arms
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06222879
Sponsor's protocol ID
HRS-8080-202
Status last verified
Jan 2024
First submitted
4 Dec 2023
Last updated
25 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-8080; SHR-A1811, HRS-8080; SHR-A2009 and SHR-A2009; SHR-1316 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Na An (+86 18500038119, na.an@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limited Toxicity（DLT） (time frame: up to 1 cycle (21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06222879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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