Advanced Solid TumorsPhase 1NCT04446260
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study testing SHR-A1811 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 35 sites in 5 countries.
Trial summary
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-A1811
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 7 Sep 2020to 4 Jun 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- LVEF ≥ 50% by either ECHO or MUGA
- Has adequate renal and hepatic function
- Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment
Who cannot join
- History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
- Known hereditary or acquired bleeding and thrombotic tendency
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
China21 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233000
Xiangya hospital central south university
Changsha, Hunan, 410008
Hunan cancer hospital
Changsha, Hunan, 410031
Sichuan Cancer Hospital
Chengdu, Sichuan, 610042
Fujian Cancer Hospital
Fujian, Fuzhou, 350000
Nanfang Hospital
Guangzhou, Guangdong, 510120
Sun Yat-Sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
The second affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, 310014
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, 310014
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Fudan Unversity Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shanghai Jiao Tong University School of Medicine Renji Hospital
Shanghai, Shanghai Municipality, 200032
Shengjing Hospital of China medical university
Shengyang, Liaoning, 110022
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Tianjin medical university cancer institute&hoospital
Tianjin, Tianjin Municipality, 300181
Zhongnan hospital of Wuhan university
Wuhan, Hubei, 430062
Hubei cancer hospital
Wuhan, Hubei, 430079
Henan cancer Hospital
Zhengzhou, Henan, 450003
Australia5 sites
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
Macquarie University Hospital
Macquarie, New South Wales, 2109
Nucleus Network
Melbourne, Victoria, 3004
Alfred Hospital
Melbourne, 3004
United States3 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Greenville Hospital System
Greenville, South Carolina, 29605
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, 10461
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 3080
Asan Medical Center
Seoul, 5505
Taiwan3 sites
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 70457
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
About this study
Official title: A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-A1811
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
be administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose escalation | Experimental | Not described Receives: Drug: SHR-A1811 |
| Part 2 PK expansion | Experimental | Not described Receives: Drug: SHR-A1811 |
| Part 3 Indication expansion | Experimental | Not described Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Frequency and seriousness of treatment emergent adverse events (TEAEs)
Measured: From Day1 to 90 days after last dose
Secondary outcomes (5)
PK parameter: Tmax of SHR-A1811
Time to maximal concentration (Tmax) of SHR-A1811
Measured: Through study completion, an average of 1 year
PK parameter: Cmax of SHR-A1811
Maximal concentration (Cmax) of SHR-A1811
Measured: Through study completion, an average of 1 year
PK parameter: AUC0-t of SHR-A1811
AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
Measured: Through study completion, an average of 1 year
Immunogenicity of SHR-A1811
Including anti-drug antibody and/or neutralizing antibody
Measured: Through study completion, an average of 1 year
Tumor response using RECIST 1.1
RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months
Measured: From first dose to disease progression or death, whichever comes first, up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start7 Sep 2020
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atridia Pty Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446260
- Sponsor's protocol ID
- SHR-A1811-I-101
- Status last verified
- Sep 2024
- First submitted
- 18 Jun 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20.
PubMed 38900984
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
- ClinicalTrials.gov ID
- NCT04446260
- Acronym / sponsor ID
- SHR-A1811-I-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Atridia Pty Ltd.
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 24 Jun 2020 (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 is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose escalation | Experimental | Drug: SHR-A1811 |
| Part 2 PK expansion | Experimental | Drug: SHR-A1811 |
| Part 3 Indication expansion | Experimental | Drug: SHR-A1811 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- LVEF ≥ 50% by either ECHO or MUGA
- Has adequate renal and hepatic function
- Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment
Key exclusion criteria (2 listed)
- History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
- Known hereditary or acquired bleeding and thrombotic tendency
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-A1811be administered via intravenous (IV) infusion | Drug | Part 1 Dose escalation, Part 2 PK expansion, Part 3 Indication expansion |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: From Day1 to 90 days after last dose
Frequency and seriousness of treatment emergent adverse events (TEAEs)
5 secondary outcomes
PK parameter: Tmax of SHR-A1811
Time frame: Through study completion, an average of 1 year
PK parameter: Cmax of SHR-A1811
Time frame: Through study completion, an average of 1 year
PK parameter: AUC0-t of SHR-A1811
Time frame: Through study completion, an average of 1 year
Immunogenicity of SHR-A1811
Time frame: Through study completion, an average of 1 year
Tumor response using RECIST 1.1
Time frame: From first dose to disease progression or death, whichever comes first, up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 38900984Yao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1811 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 35 sites in 5 countries.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China, Australia, United States, South Korea, Taiwan. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: From Day1 to 90 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446260, which also lists 1 linked publication.
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 2025.