Breast CancerPhase 2NCT05353361
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
A Phase 2 study testing SHR-A1811：Pyrotinib, SHR-A1811；Pertuzumab and SHR-A1811；Adebrelimab in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with 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?
- SHR-A1811：Pyrotinib, SHR-A1811；Pertuzumab and SHR-A1811；Adebrelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2022to 31 Dec 2025
- 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
- Women aged 18 to 75 (inclusive)
- Breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Have adequate renal and hepatic function
- Patients voluntarily joined the study and signed informed consent
Who cannot join
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
- Any active autoimmune disease or a history of autoimmune disease
Show all 13Show fewer
- A history of immune deficiency
- Clinically significant cardiovascular disorders
- Clinically significant history of lung disease
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- Known hereditary or acquired bleeding tendency
- Active hepatitis and liver cirrhosis
- Presence of other serious physical or mental diseases or laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Yongmei Yin
Jinhai Tang
About this study
Official title: A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811：Pyrotinib, SHR-A1811；Pertuzumab, SHR-A1811；Adebrelimab, SHR-A1811；Albumin paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811：PyrotinibDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral
SHR-A1811；PertuzumabDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
SHR-A1811；AdebrelimabDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip
SHR-A1811；Albumin paclitaxelDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811combined Pyrotinib | Experimental | Not described Receives: Drug: SHR-A1811：Pyrotinib |
| SHR-A1811Combined Pertuzumab | Experimental | Not described Receives: Drug: SHR-A1811；Pertuzumab |
| SHR-A1811Combined Adebrelimab | Experimental | Not described Receives: Drug: SHR-A1811；Adebrelimab |
| SHR-A1811Combined Albumin-bound Paclitaxel | Experimental | Not described Receives: Drug: SHR-A1811；Albumin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT（Phase I (dose exploration phase) ）
Measured: 21 days after the first administration of each subject
AE（Phase I (dose exploration phase) ）
Measured: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）
Measured: from Day1 to 40 or 90 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Measured: Two years after the last subject was enrolled in the group
Secondary outcomes (21)
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Measured: through study completion, an average of 2 years
Objective Response Rate（Phase I secondary endpoint）
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response（Phase I secondary endpoint）
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase I secondary endpoint）
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
AE（Phase II secondary study endpoint）
Measured: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Measured: from Day1 to 40 or 90 days after last dose
PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）
Measured: through study completion, an average of 2 years
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
Measured: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Measured: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Measured: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Measured: through study completion, an average of 2 years
Duration of response（Phase II secondary study endpoint）
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase II secondary study endpoint）
Measured: from first dose to disease progression, or death, whichever comes first, up to 3 years
Event-Free Survival Rate（Phase II secondary study endpoint）
Measured: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start23 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, open-label, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration phase, which uses the 3 + 3 escalation design; The second stage is the curative effect expansion phase.
- Masking
- None (open label)
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353361
- Sponsor's protocol ID
- SHR-A1811-II-202
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer
- ClinicalTrials.gov ID
- NCT05353361
- Acronym / sponsor ID
- SHR-A1811-II-202
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2022 (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.
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a multicenter, open-label, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration phase, which uses the 3 + 3 escalation design; The second stage is the curative effect expansion phase.
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811combined Pyrotinib | Experimental | Drug: SHR-A1811：Pyrotinib |
| SHR-A1811Combined Pertuzumab | Experimental | Drug: SHR-A1811；Pertuzumab |
| SHR-A1811Combined Adebrelimab | Experimental | Drug: SHR-A1811；Adebrelimab |
| SHR-A1811Combined Albumin-bound Paclitaxel | Experimental | Drug: SHR-A1811；Albumin paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 to 75 (inclusive)
- Breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
Key exclusion criteria (13 listed)
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
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-A1811：PyrotinibSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral | Drug | SHR-A1811combined Pyrotinib |
| SHR-A1811；PertuzumabSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip | Drug | SHR-A1811Combined Pertuzumab |
| SHR-A1811；AdebrelimabSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip | Drug | SHR-A1811Combined Adebrelimab |
| SHR-A1811；Albumin paclitaxelSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip | Drug | SHR-A1811Combined Albumin-bound Paclitaxel |
Primary outcome
DLT（Phase I (dose exploration phase) ）
Time frame: 21 days after the first administration of each subject
AE（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 or 90 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Time frame: Two years after the last subject was enrolled in the group
21 secondary outcomes
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Time frame: through study completion, an average of 2 years
Objective Response Rate（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase I secondary endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
AE（Phase II secondary study endpoint）
Time frame: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Time frame: from Day1 to 40 or 90 days after last dose
PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Time frame: through study completion, an average of 2 years
Duration of response（Phase II secondary study endpoint）
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase II secondary study endpoint）
Time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
Event-Free Survival Rate（Phase II secondary study endpoint）
Time frame: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
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：Pyrotinib, SHR-A1811；Pertuzumab and SHR-A1811；Adebrelimab in people with Breast Cancer, run by Jiangsu HengRui 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 7 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 15 Sep 2023. 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 Xiaoxue Pi (0518-82342973, Xiaoxue.pi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT（Phase I (dose exploration phase) ） (time frame: 21 days after the first administration of each subject). The study lists 4 primary outcomes in all. 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 15 Sep 2023.