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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233060
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: CS3005 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects With Advanced Solid Tumors
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: CS3005 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)




Primary Outcome Measures :
  1. 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 ]


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
Criteria

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


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): NCT04233060


Contacts
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Contact: Wendie Yuan 8617621040459 ext 8617621040459 cstonera@cstonepharma.com

Locations
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Australia, New South Wales
Scientia Clinical Research Ltd Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Charlotte Lemech         
Sponsors and Collaborators
CStone Pharmaceuticals
Investigators
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Study Director: Fei Li, PhD CStone Pharmaceuticals
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04233060    
Other Study ID Numbers: CS3005-101
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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