A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT03312842
- Lead Sponsor
- CStone Pharmaceuticals
- Brief Summary
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- ECOG performance status of 0 or 1.
- Subjects must have at least one measurable lesion.
- Patients with life expectancy ≥ 3 months.
- Subject must have adequate organ function.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration.
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Known history of HIV infection.
- Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- Known history of alcoholism or drugs abuse.
For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CS1001 CS1001 -
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of CS1001 From first dose to 30 days after last dose of CS1001, up to 2 years To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001 From first dose to 30 days after last dose of CS1001, up to 2 years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Beijing Cancer Hospital🇨🇳Beijing, Beijing, China