Clinical Trials /

A Study of CS1001 in Subjects With Advanced Solid Tumors

NCT03744403

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of CS1001 in Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CS1001-102
  • NCT ID: NCT03744403

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
CS1001CS1001 monoclonal antibody

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CS1001 monoclonal antibodyExperimental
  • CS1001

Eligibility Criteria

        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
        cstonera@cstonepharma.com
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:From first dose to 90 days after last dose of CS1001, up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CStone Pharmaceuticals

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