A Study of CS1001 in Subjects with Advanced Solid Tumors

NCT03744403 | Completed Phase 1 FDA Drug

• 1 other identifier: CS1001-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  From first dose to 90 days after last dose of CS1001, up to 2 years

Study Arms (1)

CS1001 monoclonal antibody

EXPERIMENTAL

Drug: CS1001

Interventions

CS1001 DRUG

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.

CS1001 monoclonal antibody

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

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: November 14, 2018
• First Posted: November 16, 2018
• Study Start: December 4, 2018
• Primary Completion: October 31, 2020
• Study Completion: July 21, 2021
• Last Updated: September 19, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)