Advanced Breast CancerPhase 2NCT06433609
Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
A Phase 2 study testing SHR-A1811, SHR-A1921 and Adebrelimab in people with Advanced Breast Cancer, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative 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-A1811, SHR-A1921 and Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2024to Nov 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);
- ECOG PS Score: 0~1;
- Histologically or cytologically confirmed HER2-negative advanced breast cancer;
- Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;
- Based on RECIST v1.1, at least one measurable lesion;
- Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;
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- Patients must have a life expectancy ≥ 6 months;
- Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
- Women of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; Men who are not surgically sterile (including those sterilized by methods other than bilateral orchiectomy [e.g., vasectomy]) and who intend to have sexual intercourse with female partners of childbearing potential must use a contraceptive method from enrollment, throughout the study, and for 6 months after the end of the study to prevent partner pregnancy;
- Available blood samples for ctDNA detection in the exploratory study;
- Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
Who cannot join
- Has known active brain metastasis which needs local therapy immediately;
- Prior use of ADCs with the same target as study drugs;
- Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
- 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;
- Use of other antitumor systemic treatment during the study;
- Has active autoimmune disease or a history of autoimmune disease;
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- Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ 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);
- Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at >10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;
- Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;
- 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 uncontrolled cardiovascular clinical symptom or disease that is not well controlled;
- 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;
- Women with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;
- 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.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Wei Zhao, +8610-50847588, Zhaow6@gobroadhealthcare.com
Wei Zhao
About this study
Official title: A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- SHR-A1811, SHR-A1921, Adebrelimab, SHR-A2102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Via intravenous infusion
SHR-A1921Drug
Via intravenous infusion
AdebrelimabDrug
Via intravenous infusion
SHR-A2102Drug
Via intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811+adebrelimab | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Adebrelimab |
| SHR-A1921+adebrelimab | Experimental | Not described Receives: Drug: SHR-A1921; Drug: Adebrelimab |
| SHR-A2102 + adebrelimab | Experimental | Not described Receives: Drug: Adebrelimab; Drug: SHR-A2102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (objective response rate) 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.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
Secondary outcomes (6)
DCR (disease control rate) 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.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
CBR (clinical benefit rate) by investigator
CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD lasting≥24 weeks (stable disease) per RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
DoR (duration of response)
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 3.5 years
PFS (progression-free survival)
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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
OS (overall survival)
OS is the time from the date of first dose until the date of death by any cause.
Measured: up to 3.5 years
Safety as assessed by percentage of patients with any Adverse Event (AE)
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: up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start5 Aug 2024
- Primary completionMar 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhao, Beijing GoBroad Hospital
- Investigators
- Wei Zhao, Principal investigator, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433609
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2024-008
- Other IDs
- BC-MUL-IIT-ADC-SHR1316
- Status last verified
- Jul 2026
- First submitted
- 23 May 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06433609
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2024-008
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811+adebrelimab | Experimental | Drug: SHR-A1811, Drug: Adebrelimab |
| SHR-A1921+adebrelimab | Experimental | Drug: SHR-A1921, Drug: Adebrelimab |
| SHR-A2102 + adebrelimab | Experimental | Drug: Adebrelimab, Drug: SHR-A2102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years to 75 years old (including boundary values);
- ECOG PS Score: 0~1;
- Histologically or cytologically confirmed HER2-negative advanced breast cancer;
- Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;
- Based on RECIST v1.1, at least one measurable lesion;
Key exclusion criteria (17 listed)
- Has known active brain metastasis which needs local therapy immediately;
- Prior use of ADCs with the same target as study drugs;
- Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
- 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;
- Use of other antitumor systemic treatment during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811Via intravenous infusion | Drug | SHR-A1811+adebrelimab |
| SHR-A1921Via intravenous infusion | Drug | SHR-A1921+adebrelimab |
| AdebrelimabVia intravenous infusion | Drug | SHR-A1811+adebrelimab, SHR-A1921+adebrelimab, SHR-A2102 + adebrelimab |
| SHR-A2102Via intravenous infusion | Drug | SHR-A2102 + adebrelimab |
Primary outcome
ORR (objective response rate) by investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
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.
6 secondary outcomes
DCR (disease control rate) by investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
CBR (clinical benefit rate) by investigator
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
DoR (duration of response)
Time frame: up to 3.5 years
PFS (progression-free survival)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
OS (overall survival)
Time frame: up to 3.5 years
Safety as assessed by percentage of patients with any Adverse Event (AE)
Time frame: up to 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhao principal investigator
Beijing GoBroad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811, SHR-A1921 and Adebrelimab in people with Advanced Breast Cancer, run by Beijing GoBroad Hospital 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 17 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. 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 Wei Zhao (+8610-50847588, Zhaow6@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (objective response rate) by investigator (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.