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

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: NCT03809767
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CS1003 monoclonal antibody Drug: CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809767


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

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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03809767     History of Changes
Other Study ID Numbers: CS1003-102
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents