Breast CancerPhase 1/2NCT05845138
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
A Phase 1/2 study testing SHR-A1811 for injection ; capecitabine in people with Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 9 sites in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression. 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 for injection ; capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesChina
- Study dates
- 25 Jul 2023to 31 Dec 2025
- 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
- Women aged 18 to 75 (inclusive).
- HER2 low expression unresectable or metastatic 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.
- Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
- Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.
Who cannot join
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
- Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
- Clinically significant cardiovascular disorders.
- Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
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- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
- Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
- Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
- Presence of other serious physical or mental diseases or laboratory abnormalities.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijng, 100000
Fei Ma
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000
Fanfan Li
- Not yet recruiting
Shandong Cancer Hospital&Institute
Jinan, Shandong, 250000
Huihui Li
- Not yet recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Yongmei Yin
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Nanning, Guangxi, 530000
Qinguo Mo
- Not yet recruiting
Shantou Central Hospital
Shantou, Guangzhou, 515000
Zhiyong Wu
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Yuee Teng
- Not yet recruiting
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000
Miaoyong Zhu
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Pilei Si
About this study
Official title: An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811 for injection ; capecitabine
- 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 for injection ; capecitabineDrug
SHR-A1811 for injection; Capecitabine tablets
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 combined with capecitabine | Experimental | Not described Receives: Drug: SHR-A1811 for injection ; capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Measured: 21 days after the first administration of each subject ]
Incidence of AEs（Phase I (dose exploration phase) ）
Measured: from Day1 to 40 days after last dose
Incidence of SAEs（Phase I (dose exploration phase) ）
Measured: from Day1 to 40 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Measured: One year after the last subject was enrolled in the group
Secondary outcomes (5)
Duration of response(DoR )
Measured: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Measured: One year after the last subject was enrolled in the group
Objective response rate（Phase I (dose exploration phase)）
Measured: One year after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Measured: from Day1 to 40 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Measured: from Day1 to 40 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start25 Jul 2023
- Primary completion31 Dec 2024 (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 Suzhou Suncadia Biopharmaceuticals 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-A1811 combined with capecitabine
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845138
- Sponsor's protocol ID
- SHR-A1811-207
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 Aug 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
- ClinicalTrials.gov ID
- NCT05845138
- Acronym / sponsor ID
- SHR-A1811-207
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2023 (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.
The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-A1811 combined with capecitabine
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 combined with capecitabine | Experimental | Drug: SHR-A1811 for injection ; capecitabine |
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).
- HER2 low expression unresectable or metastatic 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 (10 listed)
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
- Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
- Clinically significant cardiovascular disorders.
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 for injection ; capecitabineSHR-A1811 for injection; Capecitabine tablets | Drug | SHR-A1811 combined with capecitabine |
Primary outcome
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Time frame: 21 days after the first administration of each subject ]
Incidence of AEs（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 days after last dose
Incidence of SAEs（Phase I (dose exploration phase) ）
Time frame: from Day1 to 40 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Time frame: One year after the last subject was enrolled in the group
5 secondary outcomes
Duration of response(DoR )
Time frame: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Time frame: One year after the last subject was enrolled in the group
Objective response rate（Phase I (dose exploration phase)）
Time frame: One year after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Time frame: from Day1 to 40 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Time frame: from Day1 to 40 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1811 for injection ; capecitabine in people with Breast Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 9 sites 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 10 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Shuchao Wu (+0518-81220121, shuchao.wu@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 ] (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 1 Aug 2023.