HER2 Expression / Amplification in Patients With Biliary Tract CancerPhase 2NCT06413745
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
A Phase 2 study testing SHR-A1811 in people with HER2 Expression / Amplification in Patients With Biliary Tract Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Expression / Amplification in Patients With Biliary Tract Cancer
- What is being tested?
- SHR-A1811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2024to 31 Jul 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 18-75 years old ( including both ends ), male or female ;
- ECOG-PS score : 0 or 1;
- Expected survival ≥ 12 weeks;
- Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
- Subjects who failed or intolerance after systemic chemotherapies;
- According to the RECIST v1.1 standard, the subjects had at least one measurable lesion；
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- The main organ function is normal, in line with the program requirements ;
- If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be < 500 IU / mL；
- Consent to contraception.
Who cannot join
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
- With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
- Severe trauma or major surgery was performed within 4 weeks before the first administration;
- To study the severe heart disease within 6 months before the first administration ;
- Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
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- Severe infection symptoms occurred within 2 weeks before the first administration;
- Known hereditary or acquired bleeding and thrombotic tendency ;
- Congenital or acquired immune defects;
- The subjects had severe and uncontrollable concomitant diseases;
- Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
- 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
SHR-A1811
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR evaluated by IRC according to RECIST v1.1 standard
Measured: About a year
Secondary outcomes (10)
DoR evaluated by IRC according to RECIST v1.1 standard
Measured: About a year
DCR evaluated by IRC according to RECIST v1.1 standard
Measured: About a year
PFS evaluated by IRC according to RECIST v1.1 standard
Measured: About a year
ORR evaluated by the researchers according to the RECIST v1.1 standard
Measured: About a year
DCR evaluated by the researchers according to the RECIST v1.1 standard
Measured: About a year
DoR evaluated by the researchers according to the RECIST v1.1 standard
Measured: About a year
PFS evaluated by the researchers according to the RECIST v1.1 standard
Measured: About a year
OS
Measured: About two year
AE
Measured: About a year
SAE
Measured: About a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start4 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 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 / Amplification in Patients With Biliary Tract 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
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
- NCT06413745
- Sponsor's protocol ID
- SHR-A1811-212
- Status last verified
- Jul 2026
- First submitted
- 9 May 2024
- Last updated
- 17 Jul 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
- ClinicalTrials.gov ID
- NCT06413745
- Acronym / sponsor ID
- SHR-A1811-212
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 May 2024 (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 was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years old ( including both ends ), male or female ;
- ECOG-PS score : 0 or 1;
- Expected survival ≥ 12 weeks;
- Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
- Subjects who failed or intolerance after systemic chemotherapies;
Key exclusion criteria (11 listed)
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
- With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
- Severe trauma or major surgery was performed within 4 weeks before the first administration;
- To study the severe heart disease within 6 months before the first administration ;
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-A1811SHR-A1811 | Drug | SHR-A1811 |
Primary outcome
ORR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
10 secondary outcomes
DoR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
DCR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
PFS evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
ORR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
DCR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
DoR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
PFS evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
OS
Time frame: About two year
AE
Time frame: About a year
SAE
Time frame: About a year
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
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 in people with HER2 Expression / Amplification in Patients With Biliary Tract Cancer, run by Jiangsu HengRui Medicine 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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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?
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?
ORR evaluated by IRC according to RECIST v1.1 standard (time frame: About a year). 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 17 Jul 2026.