A Study of CS1001 in Subjects With Advanced Solid Tumors

Sponsor

CStone Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03744403

Collaborator

(none)

Enrollment

Location

Arm

31.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: CS1001	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 4, 2018

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Jul 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CS1001 monoclonal antibody	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.

Arm

Intervention/Treatment

Experimental: CS1001 monoclonal antibody

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.

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [From first dose to 90 days after last dose of CS1001, up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
ECOG performance status of 0 or 1.
Subjects must have at least one measurable lesion.
Patients with life expectancy ≥ 3 months.
Subject must have adequate organ function.
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:

Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4.
Known history of HIV infection.
Subjects with active Hepatitis B or C infection.
Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Known history of alcoholism or drugs abuse.
Subjects who received organ transplantation.
Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEXT Oncology	San Antonio	Texas	United States	78229

Sponsors and Collaborators

CStone Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CStone Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03744403

Other Study ID Numbers:

CS1001-102

First Posted:

Nov 16, 2018

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Feb 16, 2022