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

Primary Purpose

Solid Tumor, Lymphoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CS1003 monoclonal antibody
Sponsored by
CStone Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willing to sign the informed consent.
  2. 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.
  3. ECOG performance status of 0 or 1.
  4. 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.
  5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
  6. Life expectancy ≥ 3 months.
  7. Subject must have adequate organ function.
  8. Use of effective contraception (males and females).

Exclusion Criteria:

  1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
  2. Subjects with active autoimmune diseases or history of autoimmune diseases.
  3. 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.
  4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
  5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
  6. History of HIV infection.
  7. Subjects with active Hepatitis B and C infection requiring therapy.
  8. Subjects with active infection of tuberculosis.
  9. History of organ transplantation.
  10. Unresolved toxicities from prior anti-cancer therapy.
  11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
  12. Subjects with major cardiovascular diseases.
  13. History of alcoholism or drugs abuse.
  14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

Sites / Locations

  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • The First Hospital of Jilin University
  • Hunan Cancer Hospital
  • West China Hospital Sichuan University
  • Guangdong Provincial People's Hospital
  • Zhejiang Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Yunnan Cancer Hospital
  • The First Affiliated Hospital of Nanchang University
  • Huashan Hospital Fudan University
  • Shanghai East Hospital
  • Shanghai pulmonary hospital
  • Zhongshan Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS1003 monoclonal antibody

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Full Information

First Posted
January 15, 2019
Last Updated
November 28, 2022
Sponsor
CStone Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03809767
Brief Title
A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CStone Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS1003 monoclonal antibody
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CS1003 monoclonal antibody
Intervention Description
CS1003 will be administered intravenously every 3 weeks.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
from the day of first dose to 90 days after last dose of CS1003

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Facility Name
Shanghai pulmonary hospital
City
Shanghai
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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