NCT07102901 Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma
| NCT ID | NCT07102901 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Advanced Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 351 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 351 participants in total. It began in 2025-09-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 2. Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening. 3. Is willing to provide an adequate tumor sample. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. Exclusion Criteria: 1. Presence of dysphagia or other factors impairing oral administration of SHR2554. 2. Has previously been treated with any enhancer of zeste homolog inhibitors. 3. Uncontrolled or significant cardiovascular disease. 4. 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. 5. Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants. 6. History of known hypersensitivity to SHR2554 or excipients. 7. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals. 8. Diagnosis of other malignancies within 5 years prior to the first dose of investigational product. 9. Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history. 10. Psychological, social, familial, or geographical factors that would prevent regular follow-up.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07102901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102901 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07102901 currently recruiting?
Yes, NCT07102901 is actively recruiting participants. Contact the research team at botao.zhu.bz19@hengrui.com for enrollment information.
Where is the NCT07102901 trial being conducted?
This trial is being conducted at Harbin, China, Zhengzhou, China.
Who is sponsoring the NCT07102901 clinical trial?
NCT07102901 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 351 participants.
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