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A Study of CS1002 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: NCT03523819
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 22, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS1002 ]
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 CS1002 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors
Brief Summary This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description:
Randomized for Part 3 of the study
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE
  • Drug: CS1002
    Dose levels will be escalated following a modified 3+3 dose escalation scheme
    Other Name: anti-CTLA 4
  • Drug: CS1003
    Fixed dose at 200mg in combination with CS1002 on a specified dose level
    Other Name: anti-PD1
Study Arms  ICMJE
  • Experimental: CS1002
    Participants will receive CS1002 intravenously at specified dose on specified days.
    Interventions:
    • Drug: CS1002
    • Drug: CS1003
  • Experimental: CS1003
    Participants will receive CS1003 intravenously at fixed dose on specified days.
    Interventions:
    • Drug: CS1002
    • Drug: CS1003
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: December 9, 2019)
108
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
18
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
  2. ECOG performance status of 0 or 1.
  3. Life expectancy ≥12 weeks.
  4. Subjects must have adequate organ function
  5. Use of effective contraception

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.
  3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
  4. Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., OX-40, CD137).
  5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.
  6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002.
  7. Receipt of live vaccine within 28 days prior to the first dose of CS1002
  8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
  9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
  10. Known history of HIV.
  11. Subjects with active Hepatitis B or C infection
  12. Subjects with active tuberculosis infection.
  13. Subjects with an active infection requiring systemic therapy.
  14. History of organ transplantation.
  15. History of alcoholism or drugs abuse.
  16. History of severe hypersensitivity reactions to other mAbs.
  17. Subjects with major cardiovascular diseases.

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: Wendie Yuan +862161097678 cstonera@cstonepharma.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523819
Other Study ID Numbers  ICMJE CS1002-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CStone Pharmaceuticals
Study Sponsor  ICMJE CStone Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wanmei Wang CStone Pharmaceuticals
PRS Account CStone Pharmaceuticals
Verification Date December 2019

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