Advanced Breast CancerPhase 2NCT06470672
Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer
A Phase 2 study testing SHR-A1921 and Adebrelimab in people with Advanced Breast Cancer and Hormone-receptor-positive Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- What is being tested?
- SHR-A1921 and Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Jul 2026
- Phase
- Phase 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
- 18 years to 75 years old, female patients with breast cancer;
- ECOG PS Score: 0~1;
- Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;
- PD-L1 positive;
- Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4/6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;
- Prior at least 1 line of systemic chemotherapy in recurrent or metastatic setting;
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- 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;
- Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
Who cannot join
- Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;
- Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;
- Prior anti-TROP-2 treatment;
- Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
- Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) 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;
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- Use of other antitumor systemic treatment during the study;
- Has active autoimmune disease or a history of autoimmune disease;
- 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;
- 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.
China1 site
Fudan Cancer Hospital
Shanghai, Shanghai Municipality, 200230
Hongxia Wang, +8621-38196379, whx365@126.com
Zhonghua Tao, +86-13774315805, drtaozhh@126.com
About this study
Official title: A Phase 2 Study of SHR-A1921 Combined Adebrelimab in Endocrine Therapy-failed HR-positive, HER2-negative Advanced Breast Cancer
Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Being tested
- SHR-A1921, Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921Drug
Anti-TROP-2 ADC
AdebrelimabDrug
PD-L1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1921+Adebrelimab | Experimental | Via intravenous infusion Receives: Drug: SHR-A1921; Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by investigator
ORR (Objective response rate) 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: At baseline, at the time point of every 6 weeks, up to 2 years
Secondary outcomes (5)
DCR by investigator
DCR (Disease control rate) 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: At baseline, at the time point of every 6 weeks, up to 2 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 2 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: Up to 2 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 2 years
Safety (incidence rate of adverse event)
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.
- First posted24 Jun 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
- Investigators
- Hongxia Wang, Principal investigator, Fudan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470672
- Sponsor's protocol ID
- BC-MUL-IIT-SHRA1921-SHR1316
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 20 Dec 2024
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of SHR-A1921 Combined Adebrelimab in Endocrine Therapy-failed HR-positive, HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06470672
- Acronym / sponsor ID
- BC-MUL-IIT-SHRA1921-SHR1316
- Conditions
- Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jun 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 ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1921+Adebrelimab | Experimental | Drug: SHR-A1921, Drug: AdebrelimabVia intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years to 75 years old, female patients with breast cancer;
- ECOG PS Score: 0~1;
- Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;
- PD-L1 positive;
- Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4/6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;
Key exclusion criteria (18 listed)
- Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;
- Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;
- Prior anti-TROP-2 treatment;
- Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
- Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;
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-A1921Anti-TROP-2 ADC | Drug | SHR-A1921+Adebrelimab |
| AdebrelimabPD-L1 inhibitor | Drug | SHR-A1921+Adebrelimab |
Primary outcome
ORR by investigator
Time frame: At baseline, at the time point of every 6 weeks, up to 2 years
ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
5 secondary outcomes
DCR by investigator
Time frame: At baseline, at the time point of every 6 weeks, up to 2 years
DoR (Duration of Response)
Time frame: Up to 2 years
PFS (Progression-Free Survival)
Time frame: Up to 2 years
OS (Overall Survival)
Time frame: Up to 2 years
Safety (incidence rate of adverse event)
Time frame: From time of informed consent provided to 3 months after the last dose of study therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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. This study is not recruiting at the moment.
Hongxia Wang principal investigator
Fudan Cancer 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-A1921 and Adebrelimab in people with Advanced Breast Cancer and Hormone-receptor-positive 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 11 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: status not confirmed, as of the sponsor's last update on 20 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongxia Wang (+8621-38196379, 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, up to 2 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 20 Dec 2024.