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New treatment option for HER2 Negative
Official title Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
ClinicalTrials.gov ID: NCT06932068
What this study is testing
What is Iparomlimab and Tuvonralimab (QL1706)?
Iparomlimab and Tuvonralimab (QL1706) is an investigational medicine, being studied as a potential treatment for her2 negative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18-75 years, gender is not limited;
- Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- HER2-negative by immunohistochemistry (IHC);
- low PD-L1 expression status (CPS \< 5);
- Has at least 1 measurable lesion as determined by RECIST 1.1;
You likely can't join if
- Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- Cardiovascular and cerebrovascular events that are not well controlled;
- Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for...
- Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control...
- Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune...
- Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a...
See the full eligibility criteria
- Aged 18-75 years, gender is not limited;
- Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- HER2-negative by immunohistochemistry (IHC);
- low PD-L1 expression status (CPS \< 5);
- Has at least 1 measurable lesion as determined by RECIST 1.1;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate organ function;
- The life expectancy is at least 3 months;
- Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.
- Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- Cardiovascular and cerebrovascular events that are not well controlled;
- 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...
- 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.);
- 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...
- 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...
- Brain metastasis or leptomeningeal metastasis;
- 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;
- 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...
- Any major surgery was performed ≤ 28 days before the first trial drug administration;
- History of allogeneic stem cell transplantation or organ transplantation;
- 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...
- Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
- 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...
- Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
- Others conditions do not meet the inclusion according to the judgment of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Binzhou, Shandong, China
- Dezhou, Shandong, China
- Dongying, Shandong, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Liaocheng, Shandong, China
- Linyi, Shandong, China
- Qingdao, Shandong, China
- Tai’an, Shandong, China
- Tengzhou, Shandong, China
- Weifang, Shandong, China
- Weihai, Shandong, China
- Yantai, Shandong, China
- Zibo, Shandong, China
- Jining, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Binzhou, Shandong, China; Dezhou, Shandong, China; Dongying, Shandong, China; Jinan, Shandong, China; Jining, Shandong, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.