A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT03312842 |
Recruitment Status :
Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : February 17, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Drug: CS1001 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 259 participants |
Allocation: | N/A |
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-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors |
Actual Study Start Date : | October 19, 2017 |
Actual Primary Completion Date : | August 16, 2021 |
Estimated Study Completion Date : | March 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CS1001 |
Drug: CS1001
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type. |
- To evaluate the safety and tolerability of CS1001 [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]
- To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001 [ Time Frame: From first dose to 30 days after last dose of CS1001, up to 2 years ]

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 to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- ECOG performance status of 0 or 1.
- Subjects must have at least one measurable lesion.
- Patients with life expectancy ≥ 3 months.
- Subject must have adequate organ function.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration.
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 should be excluded.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Known history of HIV infection.
- Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
- Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- Known history of alcoholism or drugs abuse.
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): NCT03312842
China, Beijing | |
Beijing Cancer Hospital | |
Beijing, Beijing, China, 100142 | |
China, Shanghai | |
Fudan University Shanghai Cancer Center | |
Shanghai, Shanghai, China |
Principal Investigator: | Lin Shen, MD | Beijing Cancer Hospital |
Responsible Party: | CStone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03312842 |
Other Study ID Numbers: |
CS1001-101 |
First Posted: | October 18, 2017 Key Record Dates |
Last Update Posted: | February 17, 2022 |
Last Verified: | February 2022 |
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.: | Yes |