Advanced Gastric CancerPhase 2NCT07102901
Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma
A Phase 2 study testing SHR2554 Tablets, SHR-A1811 Injection and SHR-A1904 Injection in people with Advanced Gastric Cancer and Metastatic Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- SHR2554 Tablets, SHR-A1811 Injection and SHR-A1904 Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 2 sitesChina
- Study dates
- 5 Sep 2025to 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
- At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
- Is willing to provide an adequate tumor sample.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
Who cannot join
- Presence of dysphagia or other factors impairing oral administration of SHR2554.
- Has previously been treated with any enhancer of zeste homolog inhibitors.
- Uncontrolled or significant cardiovascular disease.
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
- History of known hypersensitivity to SHR2554 or excipients.
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- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
- Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.
- Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
- Psychological, social, familial, or geographical factors that would prevent regular follow-up.
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
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, +86-13845120210, yanqiaozhanggcp@163.com
Yanqiao Zhang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, +86-13938244776, fengw010@163.com
Feng Wang
About this study
Official title: A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma
This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Conditions
- Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Being tested
- SHR2554 Tablets, SHR-A1811 Injection, SHR-A1904 Injection, SHR-1701 Injection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554 TabletsDrug
Oral SHR2554 tablets.
SHR-A1811 InjectionDrug
SHR-A1811 for injection.
SHR-A1904 InjectionDrug
SHR-A1904 for injection.
SHR-1701 InjectionDrug
SHR-1701 injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR2554 Tablets; Drug: SHR-A1811 Injection |
| Treatment group B | Experimental | Not described Receives: Drug: SHR2554 Tablets; Drug: SHR-A1904 Injection |
| Treatment group C | Experimental | Not described Receives: Drug: SHR2554 Tablets; Drug: SHR-1701 Injection |
| Treatment group D | Experimental | Not described Receives: Drug: SHR2554 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs).
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to approximately 2 years.
Incidence of Dose Limited Toxicity (DLT).
Measured: Up to Day 21.
Objective response rate (ORR) by the investigator assessment.
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.
Measured: Up to approximately 1 year.
Secondary outcomes (4)
Duration of objective tumor response (DoR).
Measured: Approximately 24 months.
Disease control rate (DCR).
Measured: Approximately 24 months.
Progression-free survival (PFS).
Measured: Approximately 24 months.
Overall survival (OS) assessed by the investigator.
Measured: Approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start5 Sep 2025
- 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 Advanced Gastric 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (estimated)
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
- NCT07102901
- Sponsor's protocol ID
- SHR2554-203-GC
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2025
- Last updated
- 10 Sep 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07102901
- Acronym / sponsor ID
- SHR2554-203-GC
- Conditions
- Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 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 is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR2554 Tablets, Drug: SHR-A1811 Injection |
| Treatment group B | Experimental | Drug: SHR2554 Tablets, Drug: SHR-A1904 Injection |
| Treatment group C | Experimental | Drug: SHR2554 Tablets, Drug: SHR-1701 Injection |
| Treatment group D | Experimental | Drug: SHR2554 Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
- Is willing to provide an adequate tumor sample.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
Key exclusion criteria (10 listed)
- Presence of dysphagia or other factors impairing oral administration of SHR2554.
- Has previously been treated with any enhancer of zeste homolog inhibitors.
- Uncontrolled or significant cardiovascular disease.
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
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 |
|---|---|---|
| SHR2554 TabletsOral SHR2554 tablets. | Drug | Treatment group A, Treatment group B, Treatment group C, Treatment group D |
| SHR-A1811 InjectionSHR-A1811 for injection. | Drug | Treatment group A |
| SHR-A1904 InjectionSHR-A1904 for injection. | Drug | Treatment group B |
| SHR-1701 InjectionSHR-1701 injection | Drug | Treatment group C |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: Up to approximately 2 years.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence and severity of serious adverse events (SAEs).
Time frame: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Dose Limited Toxicity (DLT).
Time frame: Up to Day 21.
Objective response rate (ORR) by the investigator assessment.
Time frame: Up to approximately 1 year.
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.
4 secondary outcomes
Duration of objective tumor response (DoR).
Time frame: Approximately 24 months.
Disease control rate (DCR).
Time frame: Approximately 24 months.
Progression-free survival (PFS).
Time frame: Approximately 24 months.
Overall survival (OS) assessed by the investigator.
Time frame: Approximately 24 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 10 Sep 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 SHR2554 Tablets, SHR-A1811 Injection and SHR-A1904 Injection in people with Advanced Gastric Cancer and Metastatic Gastric Cancer, run by Jiangsu HengRui Medicine 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 4 inclusion and 10 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 10 Sep 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 Botao Zhu (+86-021-23511999, botao.zhu.bz19@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs). (time frame: Up to approximately 2 years.). The study lists 4 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 10 Sep 2025.