A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

Sponsor

CStone Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03809767

Collaborator

(none)

107

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 CS1003 in subjects with advanced solid tumors or lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Lymphoma	Drug: CS1003 monoclonal antibody	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

Actual Study Start Date :

Oct 29, 2018

Actual Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CS1003 monoclonal antibody	Drug: CS1003 monoclonal antibody CS1003 will be administered intravenously every 3 weeks.

Arm

Intervention/Treatment

Experimental: CS1003 monoclonal antibody

Drug: CS1003 monoclonal antibody

CS1003 will be administered intravenously every 3 weeks.

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [from the day of first dose to 90 days after last dose of CS1003]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Willing to sign the informed consent.
Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
ECOG performance status of 0 or 1.
Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
Life expectancy ≥ 3 months.
Subject must have adequate organ function.
Use of effective contraception (males and females).

Exclusion Criteria:

Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
Subjects with active autoimmune diseases or history of autoimmune diseases.
Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
History of HIV infection.
Subjects with active Hepatitis B and C infection requiring therapy.
Subjects with active infection of tuberculosis.
History of organ transplantation.
Unresolved toxicities from prior anti-cancer therapy.
History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
Subjects with major cardiovascular diseases.
History of alcoholism or drugs abuse.
Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing		China

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:

NCT03809767

Other Study ID Numbers:

CS1003-102

First Posted:

Jan 18, 2019

Last Update Posted:

May 23, 2022

Last Verified:

Jan 1, 2022

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

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

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lymphoma

Antibodies

Antibodies, Monoclonal

Study Results

No Results Posted as of May 23, 2022