> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-clinical-study-of-shr-a1811-combined-with-c86a4569-9460-4bb7-8213-9c3a70626f45 > Record changed: 2026-11-04 # A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer. NCT05792410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) Start date 2023-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Short title** A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Dates **Completion date** 2025-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **First posted** 2023-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Registry last updated** 2023-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Primary completion date** 2024-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Start date** 2023-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Identifiers **Registry ID** NCT05792410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **ClinicalTrials.gov ID** NCT05792410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Outcomes ### Primary outcomes 1. DLT(Phase I (dose-finding phase) main study endpoint) Timeframe: 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. 2. AE(Phase I (dose-finding phase) main study endpoint) Timeframe: Up to follow-up period, approximately 24 months 3. Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint) Timeframe: Up to follow-up period, approximately 24 months 4. Objective response rate(The main end points of the second stage (efficacy expansion stage)) Timeframe: Until progression, assessed up to approximately 24 months ### Secondary outcomes 1. SHR-A1811 sparse PK concentrations in serum Timeframe: While on study drug up to study completion, approximately 24 months 2. Dalpiciclib sparse PK concentrations in plasm Timeframe: While on study drug up to study completion, approximately 24 months 3. Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time Timeframe: Up to follow-up period, approximately 24 months 4. Incidence of neutralizing antibody (NAb) to SHR-A1811 over time Timeframe: Up to follow-up period, approximately 24 months 5. Duration of response (DoR) Timeframe: Until progression or death, assessed up to approximately 24 months 6. Progression-free survival (PFS) Timeframe: Until progression or death, assessed up to approximately 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. 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 2. 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 3. ECOG Performance Status of 0 or 1 4. Patient must have adequate tumor sample for biomarker assessment 5. At least one measurable lesion 6. Adequate organ function ### Exclusion criteria 1. There are untreated or active central nervous system (CNS) tumor metastases 2. 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) 3. Major surgery within 4 weeks prior to enrollment 4. Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc 5. Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening 6. Uncontrolled intercurrent illness 7. Uncontrolled or significant cardiovascular disease 8. Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. 9. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05792410) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Dalpiciclib](https://trialight.com/data/asset/dalpiciclib-2001da9e-4c75-4a18-ae80-97f8c567dba5.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Trastuzumab rezetecan](https://trialight.com/data/asset/trastuzumab-rezetecan-ff208505-42a4-4c94-aaa2-807da0cdd343.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (6) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [ESR2](https://trialight.com/data/target/esr2-3e669f23-0238-54c8-a6ae-0a2fc6dabdfa.md) - [GPER1](https://trialight.com/data/target/gper1-18be5631-7c1d-5226-bfc4-aa64e895c39c.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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