Status:
COMPLETED
A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
Lead Sponsor:
CStone Pharmaceuticals
Conditions:
Advanced Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT03312842
Start Date
October 19 2017
End Date
February 16 2022
Last Update
May 26 2022
Active Locations (2)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China