HER2 Low Advanced or Metastatic Breast CancerPhase 1/2NCT05792410
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
A Phase 1/2 study testing SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant and SHR-A1811 & Bevacizumab injection in people with HER2 Low Advanced or Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2 Low Advanced or Metastatic Breast Cancer
- What is being tested?
- SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant and SHR-A1811 & Bevacizumab injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to 27 Feb 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
- Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
- When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
- ECOG Performance Status of 0 or 1
- Patient must have adequate tumor sample for biomarker assessment
- At least one measurable lesion
- Adequate organ function
Who cannot join
- There are untreated or active central nervous system (CNS) tumor metastases
- There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
- Major surgery within 4 weeks prior to enrollment
- Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
- Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
- Uncontrolled intercurrent illness
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- Uncontrolled or significant cardiovascular disease
- Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
- According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
- Being tested
- SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant, SHR-A1811 & Bevacizumab injection
- 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 & Dalpiciclib Isethionate TabletsDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
SHR-A1811 & FulvestrantDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular
SHR-A1811 & Bevacizumab injectionDrug
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 combined with Dalpiciclib Isethionate Tablets | Experimental | Not described Receives: Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets |
| SHR-A1811 combined with Fulvestrant | Experimental | Not described Receives: Drug: SHR-A1811 & Fulvestrant |
| SHR-A1811 combined with Bevacizumab injection | Experimental | Not described Receives: Drug: SHR-A1811 & Bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT(Phase I (dose-finding phase) main study endpoint)
Measured: At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.
AE(Phase I (dose-finding phase) main study endpoint)
Measured: Up to follow-up period, approximately 24 months
Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
Measured: Up to follow-up period, approximately 24 months
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Measured: Until progression, assessed up to approximately 24 months
Secondary outcomes (6)
SHR-A1811 sparse PK concentrations in serum
Measured: While on study drug up to study completion, approximately 24 months
Dalpiciclib sparse PK concentrations in plasm
Measured: While on study drug up to study completion, approximately 24 months
Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
Measured: Up to follow-up period, approximately 24 months
Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
Measured: Up to follow-up period, approximately 24 months
Duration of response (DoR)
Measured: Until progression or death, assessed up to approximately 24 months
Progression-free survival (PFS)
Measured: Until progression or death, assessed up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startApr 2023 (estimated)
- Primary completion27 Feb 2024 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Low Advanced or Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT05792410
- Sponsor's protocol ID
- SHR-A1811-206
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 31 Mar 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT05792410
- Acronym / sponsor ID
- SHR-A1811-206
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2023 (estimated)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 31 Mar 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.
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 combined with Dalpiciclib Isethionate Tablets | Experimental | Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets |
| SHR-A1811 combined with Fulvestrant | Experimental | Drug: SHR-A1811 & Fulvestrant |
| SHR-A1811 combined with Bevacizumab injection | Experimental | Drug: SHR-A1811 & Bevacizumab injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
- When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
- ECOG Performance Status of 0 or 1
- Patient must have adequate tumor sample for biomarker assessment
- At least one measurable lesion
Key exclusion criteria (9 listed)
- There are untreated or active central nervous system (CNS) tumor metastases
- There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
- Major surgery within 4 weeks prior to enrollment
- Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
- Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
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 & Dalpiciclib Isethionate TabletsSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral | Drug | SHR-A1811 combined with Dalpiciclib Isethionate Tablets |
| SHR-A1811 & FulvestrantSHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular | Drug | SHR-A1811 combined with Fulvestrant |
| SHR-A1811 & Bevacizumab injectionSHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip | Drug | SHR-A1811 combined with Bevacizumab injection |
Primary outcome
DLT(Phase I (dose-finding phase) main study endpoint)
Time frame: At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.
AE(Phase I (dose-finding phase) main study endpoint)
Time frame: Up to follow-up period, approximately 24 months
Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
Time frame: Up to follow-up period, approximately 24 months
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Time frame: Until progression, assessed up to approximately 24 months
6 secondary outcomes
SHR-A1811 sparse PK concentrations in serum
Time frame: While on study drug up to study completion, approximately 24 months
Dalpiciclib sparse PK concentrations in plasm
Time frame: While on study drug up to study completion, approximately 24 months
Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
Time frame: Up to follow-up period, approximately 24 months
Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
Time frame: Up to follow-up period, approximately 24 months
Duration of response (DoR)
Time frame: Until progression or death, assessed up to approximately 24 months
Progression-free survival (PFS)
Time frame: Until progression or death, assessed up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant and SHR-A1811 & Bevacizumab injection in people with HER2 Low Advanced or Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
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 6 inclusion and 9 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT(Phase I (dose-finding phase) main study endpoint) (time frame: At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.). 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 31 Mar 2023.