A Study of CS1002 in Subjects With Advanced Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523819
• Other study ID #: CS1002-101
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: January 18, 2022

Study information

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

Clinical Trial Summary

This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.

2. ECOG performance status of 0 or 1.

3. Life expectancy =12 weeks.

4. Subjects must have adequate organ function

5. Use of effective contraception

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.

2. Subjects with active autoimmune diseases or history of autoimmune diseases.

3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.

4. Has received prior therapy with an anti-CTLA-4 agent.

5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.

6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002.

7. Receipt of live vaccine within 28 days prior to the first dose of CS1002

8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.

9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.

10. Known history of HIV.

11. Subjects with active Hepatitis B or C infection

12. Subjects with active tuberculosis infection.

13. Subjects with an active infection requiring systemic therapy.

14. History of organ transplantation.

15. History of alcoholism or drugs abuse.

16. History of severe hypersensitivity reactions to other mAbs.

17. Subjects with major cardiovascular diseases. For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• CS1002
Dose levels will be escalated following a modified 3+3 dose escalation scheme
• CS1003
Fixed dose at 200mg in combination with CS1002 on a specified dose level

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre Research	Adelaide	South Australia
Australia	Border Medical Oncology Research Unit	Albury	New South Wales
Australia	Cabrini Health	Malvern	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Boxhill Hospital	Melbourne	Victoria
Australia	Orange Health Service	Orange	New South Wales
Australia	St Vincent's hospital	Sydney	New South Wales
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From the day of first dose to 30 days after last dose of CS1002