A Study of CS1002 in Subjects With Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03523819 |
Recruitment Status :
Completed
First Posted : May 14, 2018
Last Update Posted : December 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor, Adult | Drug: CS1002 Drug: CS1003 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Masking Description: | Randomized for Part 3 of the study |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 26, 2018 |
Actual Primary Completion Date : | January 18, 2022 |
Actual Study Completion Date : | January 18, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CS1002
Participants will receive CS1002 intravenously at specified dose on specified days.
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Drug: CS1002
Dose levels will be escalated following a modified 3+3 dose escalation scheme
Other Name: anti-CTLA 4 Drug: CS1003 Fixed dose at 200mg in combination with CS1002 on a specified dose level
Other Name: anti-PD1 |
Experimental: CS1003
Participants will receive CS1003 intravenously at fixed dose on specified days.
|
Drug: CS1002
Dose levels will be escalated following a modified 3+3 dose escalation scheme
Other Name: anti-CTLA 4 Drug: CS1003 Fixed dose at 200mg in combination with CS1002 on a specified dose level
Other Name: anti-PD1 |
- Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS1002 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Subjects must have adequate organ function
- Use of effective contraception
Exclusion Criteria:
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Subjects with active autoimmune diseases or history of autoimmune diseases.
- Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
- Has received prior therapy with an anti-CTLA-4 agent.
- 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.
- 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.
- Receipt of live vaccine within 28 days prior to the first dose of CS1002
- Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
- Known history of HIV.
- Subjects with active Hepatitis B or C infection
- Subjects with active tuberculosis infection.
- Subjects with an active infection requiring systemic therapy.
- History of organ transplantation.
- History of alcoholism or drugs abuse.
- History of severe hypersensitivity reactions to other mAbs.
- Subjects with major cardiovascular diseases.
For more information regarding trial participation, please contact at cstonera@cstonepharma.com

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523819
Australia, New South Wales | |
Border Medical Oncology Research Unit | |
Albury, New South Wales, Australia, 2640 | |
Orange Health Service | |
Orange, New South Wales, Australia, 2800 | |
St Vincent's hospital | |
Sydney, New South Wales, Australia, 2010 | |
Southern Medical Day Care Centre | |
Wollongong, New South Wales, Australia, 2500 | |
Australia, South Australia | |
Ashford Cancer Centre Research | |
Adelaide, South Australia, Australia, 5037 | |
Australia, Victoria | |
Cabrini Health | |
Malvern, Victoria, Australia, 3186 | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Boxhill Hospital | |
Melbourne, Victoria, Australia, 3128 | |
Hong Kong | |
Prince of Wales Hospital | |
Hong Kong, Hong Kong | |
Queen Mary Hospital | |
Hong Kong, Hong Kong |
Study Director: | Wanmei Wang | CStone Pharmaceuticals |
Responsible Party: | CStone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03523819 |
Other Study ID Numbers: |
CS1002-101 |
First Posted: | May 14, 2018 Key Record Dates |
Last Update Posted: | December 16, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Solid Tumors |
Neoplasms |