HER2-positive Locally Advanced or Metastatic Biliary Tract CancerPhase 2NCT06778031
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
A Phase 2 study testing SHR-A1811, SHR-1316 and SHR-8068 in people with HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
- What is being tested?
- SHR-A1811, SHR-1316 and SHR-8068
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesChina
- Study dates
- 26 Feb 2025to Sep 2028
- 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;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
- According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
- The main organ function is normal, in line with the program requirements;
- Consent to contraception.
Who cannot join
- Other active malignancies within 5 years or at the same time;
- Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
- Subjects with biliary obstruction should be excluded;
- There is active autoimmune disease or a history of autoimmune disease that may recur;
- Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
- Severe infection within 4 weeks prior to initiation of study treatment;
- Active hepatitis B virus (HBV) infection;
- Have serious cardiovascular and cerebrovascular diseases.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Tongsen Zheng, 15134569619, zhengtongsen@126.com
Tongsen Zheng
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jian Zhou, 021-64041990, zhou.jian@zs-hospital.sh.cn
Jian Zhou
About this study
Official title: An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
- Being tested
- SHR-A1811, SHR-1316, SHR-8068
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811.
SHR-1316Drug
SHR-1316.
SHR-8068Drug
SHR-8068.
| Study group | Role | What they receive |
|---|---|---|
| The SHR-A1811 combination group | Experimental | Not described Receives: Drug: SHR-A1811; Drug: SHR-1316; Drug: SHR-8068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators
Measured: Screening up to study completion, an average of 3 year.
Secondary outcomes (5)
Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators
Measured: Screening up to study completion, an average of 3 year.
Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators
Measured: Screening up to study completion, an average of 3 year.
Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators
Measured: Screening up to study completion, an average of 3 year.
Overall survival (OS) of the SHR-A1811 combination evaluated by investigators
Measured: Screening up to study completion, an average of 3 year.
Adverse events (AEs)
Measured: Screening up to study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start26 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Locally Advanced or Metastatic Biliary Tract CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT06778031
- Sponsor's protocol ID
- SHR-A1811-215
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2025
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06778031
- Acronym / sponsor ID
- SHR-A1811-215
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Jan 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.
This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The SHR-A1811 combination group | Experimental | Drug: SHR-A1811, Drug: SHR-1316, Drug: SHR-8068 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old (including both ends), male or female;
- ECOG-PS score: 0 or 1;
- Expected survival ≥ 12 weeks;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
Key exclusion criteria (8 listed)
- Other active malignancies within 5 years or at the same time;
- Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
- Subjects with biliary obstruction should be excluded;
- There is active autoimmune disease or a history of autoimmune disease that may recur;
- Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
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 | The SHR-A1811 combination group |
| SHR-1316SHR-1316. | Drug | The SHR-A1811 combination group |
| SHR-8068SHR-8068. | Drug | The SHR-A1811 combination group |
Primary outcome
Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators
Time frame: Screening up to study completion, an average of 3 year.
5 secondary outcomes
Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators
Time frame: Screening up to study completion, an average of 3 year.
Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators
Time frame: Screening up to study completion, an average of 3 year.
Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators
Time frame: Screening up to study completion, an average of 3 year.
Overall survival (OS) of the SHR-A1811 combination evaluated by investigators
Time frame: Screening up to study completion, an average of 3 year.
Adverse events (AEs)
Time frame: Screening up to study completion, an average of 3 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 6 Mar 2025.
- 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.
2 sites 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, SHR-1316 and SHR-8068 in people with HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 8 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tingting Lei, BM (+86-18610051325, tingting.lei.tl6@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators (time frame: Screening up to study completion, an average of 3 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 6 Mar 2025.