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A 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. Identifier: NCT03744403
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : February 16, 2022
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
This is a phase I, open-label, multiple-dose, dose-escalation 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 Solid Tumors Drug: CS1001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : July 21, 2021

Arm Intervention/treatment
Experimental: CS1001 monoclonal antibody 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, both dose levels will be expanded.

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From first dose to 90 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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
  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 prior therapies targeting PD-1, PD-L1, or CTLA-4.
  4. Known history of HIV infection.
  5. Subjects with active Hepatitis B or C infection.
  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.
  9. Subjects who received organ transplantation.
  10. Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
  11. Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.

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): NCT03744403

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United States, Texas
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
CStone Pharmaceuticals
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Responsible Party: CStone Pharmaceuticals Identifier: NCT03744403    
Other Study ID Numbers: CS1001-102
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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