Solid TumorPhase 1NCT07275242
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor
A Phase 1 study testing SHR-A1811 Subcutaneous Injection and SHR-A1811 for Injection in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SHR-A1811 Subcutaneous Injection and SHR-A1811 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- ≥18 years of age;
- Solid Tumor 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
- With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
- Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
- History of immunodeficiency;
- Clinically significant cardiovascular diseases;
- Known or suspected interstitial lung disease;
- Known hereditary or acquired bleeding thrombotic tendency;
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- Active hepatitis and liver cirrhosis;
- Known allergic history of the drug components of this protocol;
- History of neurological or psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Erwei Song, +86-020-81332507, songew@mail.sysu.edu.cn
Herui Yao, +86-020-81332507, yaoherui@163.com
About this study
Official title: An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
- Conditions
- Solid Tumor
- Being tested
- SHR-A1811 Subcutaneous Injection, SHR-A1811 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 Subcutaneous InjectionDrug
SHR-A1811 subcutaneous injection.
SHR-A1811 for InjectionDrug
SHR-A1811 for injection.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Group | Experimental | Not described Receives: Drug: SHR-A1811 Subcutaneous Injection; Drug: SHR-A1811 for Injection |
| Medium-Dose Group | Experimental | Not described Receives: Drug: SHR-A1811 Subcutaneous Injection; Drug: SHR-A1811 for Injection |
| High-Dose Group | Experimental | Not described Receives: Drug: SHR-A1811 Subcutaneous Injection; Drug: SHR-A1811 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
Measured: About 72 weeks.
The incidence and severity of Dose-Limiting Toxicities (DLTs)
Measured: About 72 weeks.
Adverse Events (AEs)
Measured: About 72 weeks.
Secondary outcomes (19)
Time to maximum concentration (Tmax)
Measured: About 72 weeks.
Maximum concentration (Cmax)
Measured: About 72 weeks.
Trough concentration (Cmin)
Measured: About 72 weeks.
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Measured: About 72 weeks.
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Measured: About 72 weeks.
Elimination half-life (t1/2)
Measured: About 72 weeks.
Mean residence time (MRT)
Measured: About 72 weeks.
Apparent clearance (CL/F)
Measured: About 72 weeks.
Apparent volume of distribution at steady state (Vss/F)
Measured: About 72 weeks.
Area under the concentration-time curve at steady state (AUCss)
Measured: About 72 weeks.
Maximum concentration at steady state (Css, max)
Measured: About 72 weeks.
Trough concentration at steady state (Css, min)
Measured: About 72 weeks.
Accumulation ratio (Rac)
Measured: About 72 weeks.
Anti-SHR-A1811 antibodies (ADA)
Measured: About 72 weeks.
Objective Response Rate (ORR)
Measured: About 72 weeks.
Duration of Response (DoR)
Measured: About 72 weeks.
Disease Control Rate (DCR)
Measured: About 72 weeks.
Progression-Free Survival (PFS)
Measured: About 72 weeks.
Overall Survival (OS)
Measured: About 72 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start23 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 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
- NCT07275242
- Sponsor's protocol ID
- SHR-A1811(sc)-101
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2025
- Last updated
- 15 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT07275242
- Acronym / sponsor ID
- SHR-A1811(sc)-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Dec 2025 (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 pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Group | Experimental | Drug: SHR-A1811 Subcutaneous Injection, Drug: SHR-A1811 for Injection |
| Medium-Dose Group | Experimental | Drug: SHR-A1811 Subcutaneous Injection, Drug: SHR-A1811 for Injection |
| High-Dose Group | Experimental | Drug: SHR-A1811 Subcutaneous Injection, Drug: SHR-A1811 for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age;
- Solid Tumor 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 (9 listed)
- With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
- Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
- History of immunodeficiency;
- Clinically significant cardiovascular diseases;
- Known or suspected interstitial lung disease;
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 Subcutaneous InjectionSHR-A1811 subcutaneous injection. | Drug | High-Dose Group, Low-Dose Group, Medium-Dose Group |
| SHR-A1811 for InjectionSHR-A1811 for injection. | Drug | High-Dose Group, Low-Dose Group, Medium-Dose Group |
Primary outcome
Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
Time frame: About 72 weeks.
The incidence and severity of Dose-Limiting Toxicities (DLTs)
Time frame: About 72 weeks.
Adverse Events (AEs)
Time frame: About 72 weeks.
19 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: About 72 weeks.
Maximum concentration (Cmax)
Time frame: About 72 weeks.
Trough concentration (Cmin)
Time frame: About 72 weeks.
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Time frame: About 72 weeks.
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: About 72 weeks.
Elimination half-life (t1/2)
Time frame: About 72 weeks.
Mean residence time (MRT)
Time frame: About 72 weeks.
Apparent clearance (CL/F)
Time frame: About 72 weeks.
Apparent volume of distribution at steady state (Vss/F)
Time frame: About 72 weeks.
Area under the concentration-time curve at steady state (AUCss)
Time frame: About 72 weeks.
Maximum concentration at steady state (Css, max)
Time frame: About 72 weeks.
Trough concentration at steady state (Css, min)
Time frame: About 72 weeks.
Accumulation ratio (Rac)
Time frame: About 72 weeks.
Anti-SHR-A1811 antibodies (ADA)
Time frame: About 72 weeks.
Objective Response Rate (ORR)
Time frame: About 72 weeks.
Duration of Response (DoR)
Time frame: About 72 weeks.
Disease Control Rate (DCR)
Time frame: About 72 weeks.
Progression-Free Survival (PFS)
Time frame: About 72 weeks.
Overall Survival (OS)
Time frame: About 72 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1811 Subcutaneous Injection and SHR-A1811 for Injection in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals 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 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhang (+86-0518-82342973, yue.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc) (time frame: About 72 weeks.). The study lists 3 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 Jan 2026.