What is iparomlimab and tuvonralimab studying for MSI-H gastric cancer?

This trial is studying iparomlimab and tuvonralimab as a first-line treatment option for recurrent or metastatic MSI-H gastric cancer. Researchers are comparing these drugs to standard chemotherapy combined with PD-1/PD-L1 antibodies to see if they offer similar benefits. The study is sponsored by Peking University.

Who may be eligible for this MSI-H gastric cancer clinical trial?

Adults aged 18 years or older with unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed as MSI-H may be eligible. Participants must not have received prior systemic anti-tumor therapy for this cancer and need to have measurable lesions. Please review eligibility criteria for more details.

Is there any cost to participate in this MSI-H gastric cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07127822

A Phase II Study Comparing Iparomlimab and Tuvonralimab Versus Standard Chemotherapy with PD-1PD-L1 Antibody for First-Line Treatment of MSI-HdMMR Recurrent or Metastatic Gastric Cancer

Led by Peking University · Updated on 2026-08-05

106

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating first-line treatment options for patients with recurrent or metastatic MSI-H gastric cancer in a phase II randomized controlled study. The trial compares the combination of iparomlimab and tuvonralimab against standard first-line chemotherapy combined with PD-1PD-L1 antibody in two separate groups. This study aims to determine if the new combination is not worse than the standard treatment in effectiveness. Participants will be randomly assigned to receive either the investigational drugs iparomlimab and tuvonralimab or standard chemotherapy regimens FOLFOX, XELOX, or SOX combined with PD-1PD-L1 antibodies. Treatments will be given as first-line therapy for their advanced gastric or gastroesophageal junction cancer. The study design allows for parallel comparison of these two treatment approaches. During the study, participants will be monitored for tumor response using measures such as objective response rate, progression-free survival, and overall survival over two years. Safety and side effects will also be tracked. Assessments include imaging, laboratory tests, and clinical evaluations at regular intervals. Participants will be involved throughout the treatment and follow-up periods, with the study expected to complete by the end of 2028.

CONDITIONS

Brief Title

Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Voluntarily willing to participate and sign informed consent
Age 18 years or older, any gender
Expected survival time of at least 3 months
Diagnosed with unresectable locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma confirmed by histological or cytological examination
Confirmed microsatellite instability-high (MSI-H) by PCR or next-generation sequencing; mismatch repair deficient patients must have MSI-H confirmation before treatment
No prior systemic anti-tumor treatment; if previously treated with curative intent, recurrence must be at least 6 months after last treatment
Agree to provide tumor tissue samples within 3 years or evaluated as eligible by researcher if unable
At least one measurable lesion defined by RECIST 1.1
ECOG performance status 0 or 1
No severe cardiac dysfunction with left ventricular ejection fraction ≥ 50%
Meet specific laboratory criteria for blood counts, chemistry, coagulation, and urine protein
Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception for at least 1 year after last treatment

You will not qualify if you...

Pregnant or lactating women
Previous use of PD-1/PD-L1 or CTLA-4 monoclonal antibodies or related drugs
Active autoimmune disease or history of autoimmune disease requiring treatment, except certain controlled conditions
Use of immunosuppressive therapy or systemic steroids above specified doses within 2 weeks before first administration
Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
Uncontrolled brain metastasis or related neurological conditions within 4 weeks prior to treatment
Recent non-systemic anti-tumor therapy within 3 weeks before treatment start
Severe or uncontrolled illnesses including poorly controlled blood pressure, recent heart problems, active infections, significant liver disease, HIV positive, or poorly controlled diabetes
Severe infections within 4 weeks prior to randomization
Allergies to recombinant humanized antibodies or drug components
History of stem cell transplantation
Serious neurological or psychiatric disorders
Active malignant tumors diagnosed within 3 years except certain skin or carcinoma in situ cases
Planned live vaccines within 28 days prior to randomization
Other conditions deemed inappropriate for participation by the researcher

Research Team

Lin Shen

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A Phase II Study Comparing Iparomlimab and Tuvonralimab Versus Standard Chemotherapy with PD-1PD-L1 Antibody for First-Line Treatment of MSI-HdMMR Recurrent or Metastatic Gastric Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria