Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination using two drugs, SHR-1501 and adbelizumab, to see if they are safe and effective for people with advanced or spreading (metastatic) cancers that have not responded to standard treatments or do not have other treatment options. The study will carefully test different doses and watch how well the treatment works and how patients tolerate it. The goal is to find the best dose to use in future studies and to learn whether this combination can help shrink tumors or slow cancer growth.

People who might be eligible to join are adults between 18 and 75 years old who have advanced solid tumors that can be measured on scans and have a good overall health status, meaning they are able to carry out daily activities with little or no symptoms from their cancer. Participants should have a life expectancy of at least three months and must be willing to take part and understand the study procedures. The trial will not include people with certain serious health issues, such as active infections, recent major surgery, certain lung or heart problems, or those who are pregnant or breastfeeding. If accepted, participants can expect to receive the study drugs under close medical supervision, with regular check-ups to monitor their response and any side effects. This study is not yet open for enrollment but aims to provide important information on a potential new cancer treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person.
• • 2. Age: 18 to 75 years old (including both ends), gender not limited.
• • 3. Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment.
• • 4. According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion;
• • 5. The ECOG physical condition score is 0 or 1.
• • 6. The expected survival time is more than 3 months;
• Exclusion Criteria:
• • 1. Symptomatic central nervous system (CNS) metastasis;
• • 2. Other malignant tumors within five years before the first use of study drugs;
• • 3. Uncontrolled tumor-related pain judged by the investigator;
• • 4. Severe cardiovascular and cerebrovascular diseases;
• • 5. Significant clinical bleeding symptoms within 3 months before the first study drug, and obvious fresh hemoptysis within 1 month before the first study drug;
• • 6. Uncontrollable pleural effusion and/or ascites judged by the study or pleural effusion and/or ascites requiring intervention within 7 days before the first treatment
• • 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or active pneumonia at screening; or other moderate to severe lung diseases that seriously affect lung function
• • 8. Severe infection within 4 weeks before the start of study treatment
• • 9. History of immunodeficiency
• • 10. Used corticosteroids (\>10 mg/day prednisone or equivalent) or other systemic immunosuppressants within 14 days before the first study drug.
• • 11. Patients with active pulmonary tuberculosis infection within 1 year before enrollment as determined by medical history or imaging examination, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment
• • 12. Patients whose adverse events caused by previous treatment have not recovered to ≤CTCAE grade 1
• • 13. Patients whose previous treatment washout does not meet the following requirements: Patients who have received chemotherapy, biological therapy, targeted therapy, immunotherapy, or other unlisted clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug
• • 14. Patients who have experienced CTCAE grade 4 or grade 3 immune-related adverse events lasting for 4 weeks or more after the previous use of immune checkpoint inhibitors are not allowed to be enrolled in this study;
• • 15. Patients who have received \>30 Gy chest radiotherapy within 24 weeks before the first use of the study drug, patients who have received \>30 Gy non-chest radiotherapy within 4 weeks before the first use of the drug (subjects who have completed brain metastasis radiotherapy 14 days before the first use of the drug can be enrolled), and patients who have received ≤30 Gy within 14 days before the first use of the drug Gy of palliative radiation;
• • 16. Subjects who have undergone surgery on important organs (excluding puncture biopsy) within 4 weeks before the first use of the study drug, have had significant trauma, or need to undergo elective surgery during the trial;
• • 17. Active, known or suspected autoimmune diseases and history of autoimmune diseases.
• • 18. Using attenuated live vaccines within 28 days before the first use of the study drug, or anticipating the need to use attenuated live vaccines during the study treatment;
• • 19. Pregnant or lactating women or female subjects who plan to become pregnant during the study and within 6 months after the last use of the study drug;
• • 20. Those who are known to be allergic to any component or excipient of the study drug; or have a history of severe allergic reactions to other monoclonal antibodies/fusion protein drugs;
• • 21. The investigators judge that the subjects have other factors that may affect the study results or force the termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of trial data.