An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. 18-75 years old ，Male or female. 3. ECOG score is 0 or 1. 4. Subjects with advanced or metastatic solid tumors that have been documented by histopathology and are not responding to or tolerated by standard treatment, or have no effective standard treatment options. 5. Have at least one measurable lesion according to RECIST v1.1 criteria. 6. Expected survival ≥3 months . 7. With good vital organ function. 8. Contraception. Exclusion Criteria: 1. With untreated or active Central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis. 2. Previous or co-existing malignant tumors. 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. Patients with uncontrolled tumor-related pain. 5. Received systemic antitumor therapy 4 weeks before starting study treatment; Previously receiving small molecule targeted therap