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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: CS1002 Drug: CS1003 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: Randomized for Part 3 of the study
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : January 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CS1002
Participants will receive CS1002 intravenously at specified dose on specified days.
 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
Experimental: CS1003
Participants will receive CS1003 intravenously at fixed dose on specified days.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS1002 ]

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. 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

Contacts and Locations
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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): NCT03523819


Contacts
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Contact: Wendie Yuan +862161097678 cstonera@cstonepharma.com

Locations
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Australia, New South Wales
St Vincent's hospital Not yet recruiting
Sydney, New South Wales, Australia, 2010
Southern Medical Day Care Centre Not yet recruiting
Wollongong, New South Wales, Australia, 2500
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Adelaide, South Australia, Australia, 5037
Sponsors and Collaborators
CStone Pharmaceuticals
Investigators
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Study Director: Wanmei Wang CStone Pharmaceuticals
More Information
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03523819    
Other Study ID Numbers: CS1002-101
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CStone Pharmaceuticals:
Solid Tumors
Additional relevant MeSH terms:
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Neoplasms