A Study of CS1001 in Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744403
• Other study ID #: CS1001-102
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2018
• Est. completion date: July 21, 2021

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 I, open-label, multiple-dose, dose-escalation 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: 24
• Est. completion date: July 21, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.

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 180 days 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 prior therapies targeting PD-1, PD-L1, or CTLA-4.

4. Known history of HIV infection.

5. Subjects with active Hepatitis B or C infection.

6. Any unresolved CTCAE Grade = 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.

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

8. Known history of alcoholism or drugs abuse.

9. Subjects who received organ transplantation.

10. Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.

11. Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

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, both dose levels will be expanded.

Locations

Country	Name	City	State
United States	NEXT Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From first dose to 90 days after last dose of CS1001, up to 2 years