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Advanced Breast CancerPhase 2NCT07041437

Study of SHR-A2102 Combined Other Antitumor Drugs in Advanced Breast Cancer

A Phase 2 study testing SHR-A2102 and Adebrelimab in people with Advanced Breast Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Our study is aimed to evaluate the efficacy and safety of SHR-A2102 combined other antitumor treatments in advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Breast Cancer
What is being tested?
SHR-A2102 and Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
30 Jun 2025to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years to 75 years old (including boundary values), patients with advanced or metastatic breast cancer;
  • ECOG PS Score: 0~1;
  • Based on RECIST v1.1, at least one measurable lesion;
  • Patients must have a life expectancy ≥ 3 months;
  • Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
  • Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy; if unneutered male subjects (including using other sterilization except bilateral orchidectomy [e.g. vasectomy]) are willing to have sexual behaviour with WOCBP, one kind of contraception must be used to prevent the pregnancy of his partner from the date of enrolment to 7 months after the last dose of study therapy);
  • Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

Who cannot join

  • Active brain metastasis; Stable brain metastasis (at least 4 weeks after intracranial local treatment, subjects should meet one of the following requirements: a. no signs of disease progression confirmed by imaging; b. no clinical symptom, and not necessary to corticosteroid or anticonvulsant therapy; c. with clinical symptom, but not necessary to increase dose of corticosteroid or combine with dexamethasone to control clinical symptom compared with intracranial local treatment) is allowed to be enrolled;
  • Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion which needs drainage again to relieve symptoms within 4 weeks after the first drainage) which is not well controlled by effective methods, e.g. drainage;
  • Other malignancy within prior 2 years with no necessary treatment (except hormone replacement treatment) for at least recent 2 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma, skin squamous cell carcinoma or papillary thyroid carcinoma;
  • Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
  • Adverse events caused by prior antitumor therapy have not recovered to ≤grade 1 per NCI-CTCAE v5.0 (except alopecia and tolerable, chronic grade 2 toxicity determined by investigator);
  • Use of other antitumor systemic treatment during the study;
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  • Has received CYP3A4, CYP2D6, P-gp or BCRP potent inhibitors or inducers <5-fold half-life of the drug before the first dose;
  • Hypersensitivity to study therapy or any of its excipients;
  • Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;
  • Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation, or known history of allogenic haemopoietic stem cell transplantation;
  • Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
  • Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
  • Known severe cardiac-cerebral vascular disease, including but not limited to: a) known severe cardiac rhythm or conduction disorder, such as ventricular arrhythmias necessary for clinical intervention, second or third degree atrioventricular block; b) under the resting state, QTcF>470ms for female or 450ms for male examined by 12-lead ECG; c) acute coronary syndrome, congestive heart failure (NYHA classification of heart failure ≥ Class II), myocardial infarction, aortic dissection, cerebral stroke, or other ≥grade 3 cardiac-cerebral vascular events; d) LVEF<50%; e) clinically uncontrolled hypertension;
  • Existence of arterial/venous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
  • (Arm 2 only) Has received or been receiving PD-1/PD-L1 inhibitor;
  • (Arm 2 only) Has active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, uveitis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, hyperthyroidism, uncontrolled hypothyroidism only treated with hormone replacement therapy); subject that has skin disease unnecessary for systemic treatment (such as vitiligo, psoriasis, alopecia), controlled type I diabetes treated with insulin, or complete remission of asthma in childhood and no need to any intervention in adulthood can be enrolled; subject that has asthma which needs medical intervention by bronchodilators can not be enrolled; subject that has been receiving chronic, systemic steroid therapy (daily dose >10mg prednisone or equivalent) or any other type of immunosuppressants within 2 weeks before the first dose of study therapy;
  • (Arm 2 only) Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;
  • Other conditions that might influence the study and analysis of results in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongxia Wang, Chief physician contact

+862138196379

whx365@126.com

Zhonghua Tao, Chief physician contact

+86-13774315805

drtaozhh@126.com

China1 site

  • Fudan Cancer Hospital

    Shanghai, Shanghai Municipality, 200230

    Hongxia Wang, Chief physician, +862138196379, whx365@126.com

    Zhonghua Tao, Chief physician, +86-13774315805, drtaozhh@126.com

Other trials in China

About this study

Official title: Efficacy and Safety Study of SHR-A2102-based Treatment in Advanced Breast Cancer

Our study is aimed to evaluate the efficacy and safety of SHR-A2102 combined other antitumor treatments in advanced breast cancer.

Being tested
SHR-A2102, Adebrelimab

What participants receive

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

  • SHR-A2102Drug

    ADC

  • AdebrelimabDrug

    PD-L1 inhibitor

Study groups in NCT07041437
Study groupRoleWhat they receive
SHR-A2102ExperimentalSingle Agent
Receives: Drug: SHR-A2102
SHR-A2102+adebrelimabExperimentalSHR-A2102 combined with adebrelimab
Receives: Drug: SHR-A2102; Drug: Adebrelimab

What is being measured

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

  1. ORR by investigator

    ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1 and will be evaluated at baseline, at the time point of every 6 weeks.

    Measured: At baseline, at the time point of every 6 weeks

Secondary outcomes (5)

  1. DCR by investigator

    DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1 and will be evaluated at baseline, at the time point of every 6 weeks.

    Measured: At baseline, at the time point of every 6 weeks

  2. DoR

    DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.

    Measured: up to 2 years

  3. PFS

    PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).

    Measured: up to 2 years

  4. OS

    OS is the time from the date of first dose until the date of death by any cause.

    Measured: up to 2 years

  5. Percentage of participants who experience an adverse event [Safety and Tolerability]

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.

    Measured: From time of informed consent provided to 3 months after the last dose of study therapy

Timeline

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

  1. First posted27 Jun 2025
  2. Study start30 Jun 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Jan 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two arms of SHR-A2102 based-treatment will be enrolled to evaluate efficacy and safety, but this is a nonrandomized design.
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07041437
Sponsor's protocol ID
BC-MUL-IIT-SHRA2102
Status last verified
Jun 2025
First submitted
19 Jun 2025
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A2102 and Adebrelimab in people with Advanced Breast Cancer, run by Fudan University 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 7 inclusion and 18 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hongxia Wang, Chief physician (+862138196379, whx365@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by investigator (time frame: At baseline, at the time point of every 6 weeks). 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 NCT07041437.

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 27 Jun 2025.

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