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Trial record 5 of 12 for:    CS1001
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A Phase Ia/Ib 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: NCT03312842
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Study Description
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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 CS1001 in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: CS1001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 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-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : August 16, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CS1001 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, patients will be assigned to different groups based on their tumor type.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety and tolerability of CS1001 [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]
  2. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001 [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
  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 immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
  4. Known history of HIV infection.
  5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
  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.

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): NCT03312842


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Sponsors and Collaborators
CStone Pharmaceuticals
Investigators
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Principal Investigator: Lin Shen, MD Beijing Cancer Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03312842    
Other Study ID Numbers: CS1001-101
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022

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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.: Yes