A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
876 participants
Feb 18, 2025
INTERVENTIONAL
Conditions
Summary
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.
Eligibility
Inclusion Criteria9
- Voluntary participation and written informed consent;
- 18-75 years older, no gender limitation;
- Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- With a life expectancy ≥ 3 months;
- Pathologically diagnosed advanced solid tumor;
- Be able to provide fresh or archived tumour tissue;
- At least one measurable lesion according to RECIST v1.1;
- Adequate bone marrow reserve and organ function;
- Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Exclusion Criteria17
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Previous or co-existing malignancies;
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
- Uncontrollable tumor-related pain;
- Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
- Received systemic antitumor therapy before the first dose;
- Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
- For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
- Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
- Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;
- A history of interstitial pneumonia/non-infectious pneumonia;
- Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
- Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
- With poorly controlled or severe cardiovascular disease;
- Active hepatitis B, hepatitis C;
- Patients with a history of immunodeficiency;
- Severe infection 30 days before the first dose.
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Interventions
SHR-1826
SHR-4642
SHR-9839
SHR-8068
Bevacizumab Injection
Fluorouracil Injection
Calcium Folinate Injection
Adebrelimab Injection
Capecitabine tablets, oral.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06703177