A Study of CS3005 in Advanced Solid Tumors

NCT04233060 | Completed Phase 1

• 1 other identifier: CS3005-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CS3005

EXPERIMENTAL

Drug: CS3005

Interventions

CS3005 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)

CS3005

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has disease that is suitable for local treatment administered with curative intent
• Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
• Patients with any condition that impairs their ability to take oral medication.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Subjects with active, known, or suspected autoimmune disease in the past 3 years prior to the start of treatment.
• History of active tuberculosis, both pulmonary and extrapulmonary.
• 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.
• Subjects with ascites, pleural effusion, pericardial effusion which cannot be reversed by appropriate interventions.
• Subjects with any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment.
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
• History of organ transplant that requires the use of immunosuppressive treatment.
• 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.
• Subjects who have received systemic anti-tumor treatments 21 days prior to the initiation of the study treatment.
• Subjects who have received treatment with approved anti-tumor Chinese herbal medicine or Chinese prepared.
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

Scientia Clinical Research Ltd

Sydney, New South Wales, 2031, Australia

Location

Study Officials

• Fei Li, PhD

  CStone Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: January 10, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 17, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

AU (1)