A Phase I Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
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ClinicalTrials.gov Identifier: NCT03809767 |
Recruitment Status :
Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor Lymphoma | Drug: CS1003 monoclonal antibody | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 136 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 29, 2018 |
Estimated Primary Completion Date : | May 30, 2020 |
Estimated Study Completion Date : | April 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: CS1003 monoclonal antibody |
Drug: CS1003 monoclonal antibody
CS1003 will be administered intravenously every 3 weeks. |
- Number of participants with adverse events [ Time Frame: from the day of first dose to 90 days after last dose of CS1003 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT03809767
Contact: Wendie Yuan | +86 21 61097678 | cstonera@cstonepharma.com |
China | |
Beijing Cancer Hospital | Recruiting |
Beijing, China |
Responsible Party: | CStone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03809767 History of Changes |
Other Study ID Numbers: |
CS1003-102 |
First Posted: | January 18, 2019 Key Record Dates |
Last Update Posted: | January 18, 2019 |
Last Verified: | January 2019 |
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 |
Additional relevant MeSH terms:
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |