A Study of CS3005 in Advanced Solid Tumors

NCT ID: NCT04233060

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2021-02-17

Brief Summary

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

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS3005

Group Type: EXPERIMENTAL

CS3005

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CStone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Li, PhD

Role: STUDY_DIRECTOR

CStone Pharmaceuticals

Locations

Scientia Clinical Research Ltd

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

CS3005-101

Identifier Type: -

Identifier Source: org_study_id