A Study of CS1002 in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Drug: CS1002; Drug: CS1003

• Registration Number: NCT03523819
• Lead Sponsor: CStone Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-22
• Study Start: 2018-04-26
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CS1002	CS1002	Participants will receive CS1002 intravenously at specified dose on specified days.
CS1002	CS1003	Participants will receive CS1002 intravenously at specified dose on specified days.
CS1003	CS1002	Participants will receive CS1003 intravenously at fixed dose on specified days.
CS1003	CS1003	Participants will receive CS1003 intravenously at fixed dose on specified days.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From the day of first dose to 30 days after last dose of CS1002

Trial Locations

Locations (10)

Southern Medical Day Care Centre; 🇦🇺 Wollongong, New South Wales, Australia

Boxhill Hospital; 🇦🇺 Melbourne, Victoria, Australia

St Vincent's hospital; 🇦🇺 Sydney, New South Wales, Australia

Border Medical Oncology Research Unit; 🇦🇺 Albury, New South Wales, Australia

Orange Health Service; 🇦🇺 Orange, New South Wales, Australia

Cabrini Health; 🇦🇺 Malvern, Victoria, Australia

Ashford Cancer Centre Research; 🇦🇺 Adelaide, South Australia, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong