Biliary Tract CancerPhase 2NCT07450976
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
A Phase 2 study testing SHR-A1904 for Injection in people with Biliary Tract Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- SHR-A1904 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesChina
- Study dates
- 25 Mar 2026to Dec 2030
- 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;
- CLDN18.2 positive expression;
- Subjects who failed or intolerance after systemic chemotherapies;
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- 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
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Other active malignancies within 5 years or at the same time;
- 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;
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- Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Hong Zhao, +86-010-87787100, zhaohong@cicams.ac.cn
Hong Zhao
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qiang Gao, +86-021-64041990, gao.qiang@zs-hospital.sh.cn
Qiang Gao
About this study
Official title: A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
- Conditions
- Biliary Tract Cancer
- Being tested
- SHR-A1904 for Injection
- 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-A1904 for InjectionDrug
SHR-A1904 for injection, different doses.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1904 Cohort A Group | Experimental | SHR-A1904 for injection, low dose. Receives: Drug: SHR-A1904 for Injection |
| SHR-A1904 Cohort B Group | Experimental | SHR-A1904 for injection, high dose. Receives: Drug: SHR-A1904 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) assessed by investigator.
Phase IIa.
Measured: Until progression, assessed up to approximately 1 year.
Secondary outcomes (9)
Disease control rate (DCR) assessed by investigator.
Phase IIa/IIb.
Measured: Approximately 1 year.
Duration of objective tumor response (DoR) assessed by investigator.
Phase IIa/IIb.
Measured: Approximately 1 year.
Time to response (TTR) assessed by investigator.
Phase IIa/IIb.
Measured: Approximately 1 year.
Progression-free survival (PFS) assessed by investigator.
Phase IIa/IIb.
Measured: Approximately 1 year.
Overall survival (OS).
Phase IIa/IIb.
Measured: Approximately 2 years.
Adverse events (AEs).
Phase IIa/IIb.
Measured: Until study completion, assessed up to approximately 1 year.
Serious adverse events (SAEs).
Phase IIa/IIb.
Measured: Until study completion, assessed up to approximately 1 year.
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA).
Phase IIa/IIb.
Measured: Approximately 6 months.
Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb).
Phase IIa/IIb.
Measured: Approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start25 Mar 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical trial is structured to proceed in two phases. Phase IIa is a randomized, open-label trial for efficacy exploration. Participants will be randomized in a 1:1 ratio into Cohort A or Cohort B to receive different doses of SHR-A1904. Phase IIb is a single-arm group for efficacy validation, the dosage of SHR-A1904 will be determined based on the efficacy and safety results from Phase IIa.
- Masking
- None (open label)
- Enrolment
- 151 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
- NCT07450976
- Sponsor's protocol ID
- SHR-A1904-201
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07450976
- Acronym / sponsor ID
- SHR-A1904-201
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Mar 2026 (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 a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The clinical trial is structured to proceed in two phases. Phase IIa is a randomized, open-label trial for efficacy exploration. Participants will be randomized in a 1:1 ratio into Cohort A or Cohort B to receive different doses of SHR-A1904. Phase IIb is a single-arm group for efficacy validation, the dosage of SHR-A1904 will be determined based on the efficacy and safety results from Phase IIa.
| Arm | Type | Receives |
|---|---|---|
| SHR-A1904 Cohort A Group | Experimental | Drug: SHR-A1904 for InjectionSHR-A1904 for injection, low dose. |
| SHR-A1904 Cohort B Group | Experimental | Drug: SHR-A1904 for InjectionSHR-A1904 for injection, high dose. |
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;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- CLDN18.2 positive expression;
Key exclusion criteria (12 listed)
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Other active malignancies within 5 years or at the same time;
- 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;
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-A1904 for InjectionSHR-A1904 for injection, different doses. | Drug | SHR-A1904 Cohort A Group, SHR-A1904 Cohort B Group |
Primary outcome
Objective response rate (ORR) assessed by investigator.
Time frame: Until progression, assessed up to approximately 1 year.
Phase IIa.
9 secondary outcomes
Disease control rate (DCR) assessed by investigator.
Time frame: Approximately 1 year.
Duration of objective tumor response (DoR) assessed by investigator.
Time frame: Approximately 1 year.
Time to response (TTR) assessed by investigator.
Time frame: Approximately 1 year.
Progression-free survival (PFS) assessed by investigator.
Time frame: Approximately 1 year.
Overall survival (OS).
Time frame: Approximately 2 years.
Adverse events (AEs).
Time frame: Until study completion, assessed up to approximately 1 year.
Serious adverse events (SAEs).
Time frame: Until study completion, assessed up to approximately 1 year.
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA).
Time frame: Approximately 6 months.
Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb).
Time frame: Approximately 6 months.
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 31 Mar 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.
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-A1904 for Injection in people with 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 9 inclusion and 12 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 31 Mar 2026. 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 Haoyang Xin (+86-0518-82342973, haoyang.xin.hx5@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) assessed by investigator. (time frame: Until progression, assessed up to approximately 1 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 31 Mar 2026.