Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for adults with a specific type of advanced stomach cancer known as HER2-negative, low PD-L1 expressing gastric or gastroesophageal junction adenocarcinoma, which cannot be surgically removed or has spread to other parts of the body. The study is looking at the safety and effectiveness of a combination of two drugs, iparomlimab and tuvonralimab, along with standard chemotherapy (XELOX). Researchers aim to find out how well this combination works and how it affects patients.

To participate in the trial, individuals must be between 18 and 75 years old and have been diagnosed with the type of cancer mentioned above. They should have a measurable tumor and have not received certain treatments recently. Participants can expect regular check-ups and monitoring throughout the study to assess their health and response to the treatment. It's important to note that those with specific health issues or previous treatments may not qualify for this trial, so potential participants should discuss their situation with their healthcare provider to see if they meet the criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-75 years, gender is not limited;
• • 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• • 3. HER2-negative by immunohistochemistry (IHC);
• • 4. low PD-L1 expression status (CPS \< 5);
• • 5. Has at least 1 measurable lesion as determined by RECIST 1.1;
• • 6. No systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• • 8. Adequate organ function;
• • 9. The life expectancy is at least 3 months;
• • 10. Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.
• Exclusion Criteria:
• • 1. Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• • 2. Cardiovascular and cerebrovascular events that are not well controlled;
• • 3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
• • 4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
• • 5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
• • 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
• • 7. Brain metastasis or leptomeningeal metastasis;
• • 8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
• • 9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
• • 10. Any major surgery was performed ≤ 28 days before the first trial drug administration;
• • 11. History of allogeneic stem cell transplantation or organ transplantation;
• • 12. Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;
• • 13. Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
• • 14. Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;
• • 15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
• • 16. Others conditions do not meet the inclusion according to the judgment of the investigator.