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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03312842
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : February 2, 2021
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 CS1001 in subjects with advanced solid tumors.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

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.

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT03312842

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Contact: Wendie Yuan +86 21 61097678

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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Sponsors and Collaborators
CStone Pharmaceuticals
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Principal Investigator: Lin Shen, MD Beijing Cancer Hospital
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Responsible Party: CStone Pharmaceuticals Identifier: NCT03312842    
Other Study ID Numbers: CS1001-101
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: July 2020

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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