A Study of SHR-4375 in Subjects With Solid Tumors
- Registration Number
- NCT06764628
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
- The subjects voluntarily joined the study and signed the ICF.
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
Exclusion Criteria
- Symptomatic, untreated or active central nervous system metastases.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group SHR-4375 -
- Primary Outcome Measures
Name Time Method Adverse events (AEs) From Day 1 to 90 days after last dose. Dose limiting toxicity (DLT) From Day 1 to 12 months. Maximal tolerable dose (MTD) From Day 1 to 12 months. Recommended phase 2 dose (RP2D) From Day 1 to 12 months.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) From Day 1 to 12 months. Objective response rate (ORR) From Day 1 to 12 months. Disease control rate (DCR) From Day 1 to 12 months. Duration of response (DOR) From Day 1 to 12 months. Overall survival (OS) From Day 1 to 12 months.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular targets does SHR-4375 inhibit in solid tumors, and how does this affect tumor growth pathways?
How does SHR-4375's efficacy in advanced solid tumors compare to standard-of-care therapies like pembrolizumab or chemotherapy?
Which biomarkers are being evaluated to predict response to SHR-4375 in patients with advanced solid tumors?
What are the common adverse events associated with SHR-4375, and what management strategies are recommended for these in clinical practice?
Are there any combination therapies involving SHR-4375 being explored for solid tumors, and how do they compare to monotherapy approaches with similar compounds like other kinase inhibitors?
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China