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A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312842
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE October 18, 2017
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE October 19, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • To evaluate the safety and tolerability of CS1001 [ Time Frame: 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 [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Safety [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]
Number of participants with adverse events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: CS1001

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Study Arms  ICMJE Experimental: CS1001
Intervention: Drug: CS1001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
280
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
300
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
  2. ECOG performance status of 0 or 1.
  3. Subjects must have at least one measurable lesion.
  4. Patients with life expectancy ≥ 3 months.
  5. Subject must have adequate organ function.
  6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration.

Exclusion Criteria:

  1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
  2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
  3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
  4. Known history of HIV infection.
  5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
  6. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
  7. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
  8. Known history of alcoholism or drugs abuse.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wendie Yuan +86 21 61097678 cstonera@cstonepharma.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03312842
Other Study ID Numbers  ICMJE CS1001-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CStone Pharmaceuticals
Study Sponsor  ICMJE CStone Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lin Shen, MD Beijing Cancer Hospital
PRS Account CStone Pharmaceuticals
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP