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A Study of CS3005 in 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: NCT04233060
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 15, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date April 27, 2022
Actual Study Start Date  ICMJE January 10, 2020
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days (±7 days) after last dose of CS3005, up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CS3005 in Advanced Solid Tumors
Official Title  ICMJE A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors
Brief Summary A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced Solid Tumors
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: CS3005
CS3005 will be orally administrated twice daily (BID) until PD, unacceptable toxicity, withdrawal of informed consent, or until maximum treatment duration per protocol (2 years)
Study Arms  ICMJE Experimental: CS3005
Intervention: Drug: CS3005
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2022)
9
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2020)
24
Actual Study Completion Date  ICMJE February 17, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

General

  1. Be willing and able to provide written informed consent form for the trial.
  2. Male or female between 18 to 75 years of age.
  3. Ability to comply with requirements of the protocol, as assessed by the investigator.
  4. Subjects who were histologically confirmed advanced solid tumor shall have progressed disease and/or experienced intolerance from prior standard therapies, or for whom no standard of care (SoC) therapies exist.
  5. Subject must have at least one measurable lesion by CT or MRI; radiographic tumor assessment should be performed within 28 days prior to the first dose of study treatment.
  6. ECOG performance status score of 0 or 1
  7. Prior immunotherapy is allowed
  8. Subjects who have previously received anti-tumor therapy will only be enrolled if the toxicities from the previous treatment have returned to the baseline level or NCI CTCAE v 5.0 grade ≤1.
  9. Subject must have adequate organ function as indicated by the following laboratory values, G-CSF or other relevant medical support within 14 days before the administration of the investigational product
  10. Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment and pass the HBV DNA titer test and HCV RNA test before being enrolled. The subject should be willing to continue effective anti-viral treatment during the study.
  11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result. Either Female or male subjects must agree to use adequate contraceptive measures.

Exclusion Criteria:

  1. Has disease that is suitable for local treatment administered with curative intent
  2. Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
  3. Patients with any condition that impairs their ability to take oral medication.
  4. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  5. Subjects with active, known, or suspected autoimmune disease in the past 3 years prior to the start of treatment.
  6. History of active tuberculosis, both pulmonary and extrapulmonary.
  7. Clinically Significant history of cardiac disease within 6 months prior to 1st dosing, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication.
  8. Subjects with ascites, pleural effusion, pericardial effusion which cannot be reversed by appropriate interventions.
  9. Subjects with any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment.
  10. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
  11. History of organ transplant that requires the use of immunosuppressive treatment.
  12. For post immunotherapy patients, with prior ≥ Grade 3, serious, or life-threatening immune-mediated reactions following prior anti-PD-(L)1 or other immune-oncology therapies.
  13. Subjects who have received systemic anti-tumor treatments 21 days prior to the initiation of the study treatment.
  14. Subjects who have received treatment with approved anti-tumor Chinese herbal medicine or Chinese prepared.
  15. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
  16. Has received treatment with non-selective adenosine antagonist or A2a receptor antagonist.
  17. Concurrent administration of strong inhibitors or inducers of CYP3A4 and CYP1A2 is not permitted

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04233060
Other Study ID Numbers  ICMJE CS3005-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CStone Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CStone Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fei Li, PhD CStone Pharmaceuticals
PRS Account CStone Pharmaceuticals
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP