HER2 Expression Gastric Cancer/Gastroesophageal Junction AdenocarcinomaPhase 2NCT05671822
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
A Phase 2 study testing SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine and SHR-A181, SHR-1701, and capecitabine in people with HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine and SHR-A181, SHR-1701, and 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
- 258 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2023to Dec 2027
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75, Male and female participants
- Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
- HER2 expression ;
- Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
- ECOG 0-1;
- The expected survival ≥3 months;
- Sufficient bone marrow and organ functions;
Who cannot join
- There were ascites, pleural effusion and pericardial effusion that needed to be treated;
- Major surgery was performed within 4 weeks;
- Have active autoimmune disease or history of autoimmune disease;
- Patients with interstitial pneumonia;
- There was severe infection within 4 weeks before starting the study treatment;
- Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
- Serious cardiovascular and cerebrovascular diseases;
- Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
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
Zhongshan Hospital, FuDan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu
About this study
Official title: A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.
The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.
- Being tested
- SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine, SHR-A181, SHR-1701, and capecitabine, SHR-A1811, SHR-1316, and capecitabine, SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 and SHR-1701Drug
(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
SHR-A1811 and capecitabineDrug
(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-A181, SHR-1701, and capecitabineDrug
(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-A1811, SHR-1316, and capecitabineDrug
(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-A1811, SHR-1316, capecitabine,and oxaliplatinDrug
(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion
SHR-A1811, SHR-1316, and 5-FUDrug
(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion
SHR-A1811, SHR-1316, and capecitabineDrug
(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；
SHR-1316 and SHR-A1811Drug
(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
SHR-A1811 and capecitabineDrug
(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-A1811, SHR-1316, and 5-FUDrug
(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion
SHR-A1811and 5-FUDrug
(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion
SHR-A1811, SHR-1316, capecitabine,and oxaliplatinDrug
(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A: SHR-A1811 and SHR-1701 | Experimental | Not described Receives: Drug: SHR-A1811 and SHR-1701 |
| Arm 1B: SHR-A1811 and capecitabine | Experimental | Not described Receives: Drug: SHR-A1811 and capecitabine |
| Arm 1C: SHR-A181, SHR-1701, and capecitabine | Experimental | Not described Receives: Drug: SHR-A181, SHR-1701, and capecitabine |
| Arm 1D: SHR-A1811, SHR-1316, and capecitabine | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, and capecitabine |
| Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
| Arm 1G: SHR-A1811, SHR-1316, and 5-FU | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, and 5-FU |
| Arm 2A: SHR-A1811, SHR-1316, and capecitabine | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, and capecitabine |
| Arm 2B: SHR-1316 and SHR-A181 | Experimental | Not described Receives: Drug: SHR-1316 and SHR-A1811 |
| Arm 2C: SHR-A1811 and capecitabine | Experimental | Not described Receives: Drug: SHR-A1811 and capecitabine |
| Arm 2D: SHR-A1811, SHR-1316, and 5-FU | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, and 5-FU |
| Arm 2E: SHR-A1811and 5-FU | Experimental | Not described Receives: Drug: SHR-A1811and 5-FU |
| Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental | Not described Receives: Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
Measured: Safety will be assessed for approximately 24 months from informed consent
Phase II: Objective Response Rate (ORR)[
Measured: An average of approximately 12 months
Secondary outcomes (8)
ORR（Phase Ib）
Measured: An average of approximately 12 months
DoR（Phase Ib）
Measured: An average of approximately 18 months
PFS（Phase Ib）
Measured: An average of approximately 18 months
OS（Phase Ib）
Measured: An average of approximately 30 months
DoR（Phase II）
Measured: An average of approximately 18 months
PFS（Phase II）
Measured: An average of approximately 18 months
OS（Phase II）
Measured: An average of approximately 30 months
Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II）
Measured: Safety will be assessed for approximately 24 months from informed consent]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start14 Mar 2023
- Primary completionDec 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 HER2 Expression Gastric Cancer/Gastroesophageal Junction AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 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
- NCT05671822
- Sponsor's protocol ID
- SHR-A1811-Ib/II-205
- Status last verified
- Apr 2025
- First submitted
- 3 Jan 2023
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05671822
- Acronym / sponsor ID
- SHR-A1811-Ib/II-205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jan 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 is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.
The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Arm 1A: SHR-A1811 and SHR-1701 | Experimental | Drug: SHR-A1811 and SHR-1701 |
| Arm 1B: SHR-A1811 and capecitabine | Experimental | Drug: SHR-A1811 and capecitabine |
| Arm 1C: SHR-A181, SHR-1701, and capecitabine | Experimental | Drug: SHR-A181, SHR-1701, and capecitabine |
| Arm 1D: SHR-A1811, SHR-1316, and capecitabine | Experimental | Drug: SHR-A1811, SHR-1316, and capecitabine |
| Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental | Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
| Arm 1G: SHR-A1811, SHR-1316, and 5-FU | Experimental | Drug: SHR-A1811, SHR-1316, and 5-FU |
| Arm 2A: SHR-A1811, SHR-1316, and capecitabine | Experimental | Drug: SHR-A1811, SHR-1316, and capecitabine |
| Arm 2B: SHR-1316 and SHR-A181 | Experimental | Drug: SHR-1316 and SHR-A1811 |
| Arm 2C: SHR-A1811 and capecitabine | Experimental | Drug: SHR-A1811 and capecitabine |
| Arm 2D: SHR-A1811, SHR-1316, and 5-FU | Experimental | Drug: SHR-A1811, SHR-1316, and 5-FU |
| Arm 2E: SHR-A1811and 5-FU | Experimental | Drug: SHR-A1811and 5-FU |
| Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental | Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 75, Male and female participants
- Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
- HER2 expression ;
- Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
- ECOG 0-1;
Key exclusion criteria (8 listed)
- There were ascites, pleural effusion and pericardial effusion that needed to be treated;
- Major surgery was performed within 4 weeks;
- Have active autoimmune disease or history of autoimmune disease;
- Patients with interstitial pneumonia;
- There was severe infection within 4 weeks before starting the study treatment;
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 and SHR-1701(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion; | Drug | Arm 1A: SHR-A1811 and SHR-1701 |
| SHR-A1811 and capecitabine(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； | Drug | Arm 1B: SHR-A1811 and capecitabine |
| SHR-A181, SHR-1701, and capecitabine(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally； | Drug | Arm 1C: SHR-A181, SHR-1701, and capecitabine |
| SHR-A1811, SHR-1316, and capecitabine(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； | Drug | Arm 1D: SHR-A1811, SHR-1316, and capecitabine |
| SHR-A1811, SHR-1316, capecitabine,and oxaliplatin(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion | Drug | Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
| SHR-A1811, SHR-1316, and 5-FU(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion | Drug | Arm 1G: SHR-A1811, SHR-1316, and 5-FU |
| SHR-A1811, SHR-1316, and capecitabine(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally； | Drug | Arm 2A: SHR-A1811, SHR-1316, and capecitabine |
| SHR-1316 and SHR-A1811(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion | Drug | Arm 2B: SHR-1316 and SHR-A181 |
| SHR-A1811 and capecitabine(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； | Drug | Arm 2C: SHR-A1811 and capecitabine |
| SHR-A1811, SHR-1316, and 5-FU(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion | Drug | Arm 2D: SHR-A1811, SHR-1316, and 5-FU |
| SHR-A1811and 5-FU(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion | Drug | Arm 2E: SHR-A1811and 5-FU |
| SHR-A1811, SHR-1316, capecitabine,and oxaliplatin(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion | Drug | Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin |
Primary outcome
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
Time frame: Safety will be assessed for approximately 24 months from informed consent
Phase II: Objective Response Rate (ORR)[
Time frame: An average of approximately 12 months
8 secondary outcomes
ORR（Phase Ib）
Time frame: An average of approximately 12 months
DoR（Phase Ib）
Time frame: An average of approximately 18 months
PFS（Phase Ib）
Time frame: An average of approximately 18 months
OS（Phase Ib）
Time frame: An average of approximately 30 months
DoR（Phase II）
Time frame: An average of approximately 18 months
PFS（Phase II）
Time frame: An average of approximately 18 months
OS（Phase II）
Time frame: An average of approximately 30 months
Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II）
Time frame: Safety will be assessed for approximately 24 months from informed consent]
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 12 Feb 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 2 study testing SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine and SHR-A181, SHR-1701, and capecitabine in people with HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, 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 8 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 12 Feb 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 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?
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 Shiwei Sun (+86 18036618554, Shiwei.sun@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) (time frame: Safety will be assessed for approximately 24 months from informed consent). The study lists 2 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 12 Feb 2026.