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出境医 / 临床实验 / A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

Study Description
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 CS1003 in subjects with advanced solid tumors or lymphoma.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Drug: CS1003 monoclonal antibody Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : April 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: CS1003 monoclonal antibody Drug: CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.
Outcome Measures
Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: from the day of first dose to 90 days after last dose of CS1003 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign the informed consent.
  2. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
  3. ECOG performance status of 0 or 1.
  4. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
  5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
  6. Life expectancy ≥ 3 months.
  7. Subject must have adequate organ function.
  8. Use of effective contraception (males and females).

Exclusion Criteria:

  1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
  2. Subjects with active autoimmune diseases or history of autoimmune diseases.
  3. Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
  4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
  5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
  6. History of HIV infection.
  7. Subjects with active Hepatitis B and C infection requiring therapy.
  8. Subjects with active infection of tuberculosis.
  9. History of organ transplantation.
  10. Unresolved toxicities from prior anti-cancer therapy.
  11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
  12. Subjects with major cardiovascular diseases.
  13. History of alcoholism or drugs abuse.
  14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
Contacts and Locations

Contacts
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Contact: Wendie Yuan +86 21 61097678 cstonera@cstonepharma.com

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Sponsors and Collaborators
CStone Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019) 		Number of participants with adverse events [ Time Frame: from the day of first dose to 90 days after last dose of CS1003 ]
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 CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
Official Title  ICMJE A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
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 CS1003 in subjects with advanced solid tumors or lymphoma.
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
  • Solid Tumor
  • Lymphoma
Intervention  ICMJE Drug: CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.
Study Arms  ICMJE Experimental: CS1003 monoclonal antibody
Intervention: Drug: CS1003 monoclonal antibody
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: January 17, 2019) 		136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing to sign the informed consent.
  2. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
  3. ECOG performance status of 0 or 1.
  4. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
  5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
  6. Life expectancy ≥ 3 months.
  7. Subject must have adequate organ function.
  8. Use of effective contraception (males and females).

Exclusion Criteria:

  1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
  2. Subjects with active autoimmune diseases or history of autoimmune diseases.
  3. Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
  4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
  5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
  6. History of HIV infection.
  7. Subjects with active Hepatitis B and C infection requiring therapy.
  8. Subjects with active infection of tuberculosis.
  9. History of organ transplantation.
  10. Unresolved toxicities from prior anti-cancer therapy.
  11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
  12. Subjects with major cardiovascular diseases.
  13. History of alcoholism or drugs abuse.
  14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
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 +86 21 61097678 cstonera@cstonepharma.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809767
Other Study ID Numbers  ICMJE CS1003-102
Has Data Monitoring Committee No
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.: 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 February 2020

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

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