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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809767
• Other study ID #: CS1003-102
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2018
• Est. completion date: June 13, 2022

Study information

• Verified date: November 2022
• Source: CStone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 13, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Drug:
• CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Hunan Cancer Hospital	Changsha
China	West China Hospital Sichuan University	Chengdu
China	Guangdong Provincial People's Hospital	Guangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Yunnan Cancer Hospital	Kunming
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Huashan Hospital Fudan University	Shanghai
China	Shanghai East Hospital	Shanghai
China	Shanghai pulmonary hospital	Shanghai
China	Zhongshan Hospital	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Henan Cancer Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		from the day of first dose to 90 days after last dose of CS1003