A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

Advanced Cancer Clinical Trial

Official title:

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312842
• Other study ID #: CS1001-101
• Status: Completed
• Phase: Phase 1
• Start date: October 19, 2017
• Est. completion date: February 16, 2022

Study information

• Verified date: February 2022
• Source: CStone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: February 16, 2022
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.

2. ECOG performance status of 0 or 1.

3. Subjects must have at least one measurable lesion.

4. Patients with life expectancy = 3 months.

5. Subject must have adequate organ function.

6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.

2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.

3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.

4. Known history of HIV infection.

5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.

6. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.

7. Known history of alcoholism or drugs abuse.

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• CS1001
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of CS1001		From first dose to 30 days after last dose of CS1001, up to 2 years
Primary	To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001		From first dose to 30 days after last dose of CS1001, up to 2 years