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A 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744403
Recruitment Status : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE December 4, 2018
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
Number of participants with adverse events [ Time Frame: From first dose to 90 days after last dose of CS1001, up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
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 Study of CS1001 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
Brief Summary This is a phase I, open-label, multiple-dose, dose-escalation 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 Solid Tumors
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, both dose levels will be expanded.
Study Arms  ICMJE Experimental: CS1001 monoclonal antibody
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2021)
24
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2018)
16
Estimated Study Completion Date  ICMJE October 31, 2021
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
  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 prior therapies targeting PD-1, PD-L1, or CTLA-4.
  4. Known history of HIV infection.
  5. Subjects with active Hepatitis B or C infection.
  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.
  9. Subjects who received organ transplantation.
  10. Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
  11. Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03744403
Other Study ID Numbers  ICMJE CS1001-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CStone Pharmaceuticals
Study Sponsor  ICMJE CStone Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CStone Pharmaceuticals
Verification Date January 2021

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