A Study of CS3005 in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: CS3005

• Registration Number: NCT04233060
• Lead Sponsor: CStone Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS3005	CS3005	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From the day of first dose to 30 days (±7 days) after last dose of CS3005, up to 2 years

Trial Locations

Locations (1)

Scientia Clinical Research Ltd; 🇦🇺 Sydney, New South Wales, Australia