A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

Conditions

Lymphoma, Solid Tumor

Brief summary

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in subjects with advanced solid tumors or lymphoma.

Gong J, Guo Y, Zhang Y, Ba Y, Chen T, Li W, Zhou C, Wang M, Yang H, Zhou Y, Cai Q, Wang Z, Huang G, Zhang W, Su R, Cai Z, Yue Z, Dou J, Li P, Wu R, Tse AN, Shen L.

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Updated efficacy and safety results from a phase 1b study of the PD-1 antagonist CS1003 combined with lenvatinib (LEN) as first-line (1L) treatment in Chinese patients (pts) with unresectable hepatocellular carcinoma (uHCC).

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Journal of Clinical Oncology2022-06-015 citations

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Interventions

DRUGCS1003 monoclonal antibody

CS1003 will be administered intravenously every 3 weeks.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Willing to sign the informed consent. 2. 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. 3. ECOG performance status of 0 or 1. 4. 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. 5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available. 6. Life expectancy ≥ 3 months. 7. Subject must have adequate organ function. 8. Use of effective contraception (males and females).

Exclusion criteria

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis. 2. Subjects with active autoimmune diseases or history of autoimmune diseases. 3. 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. 4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib 5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc. 6. History of HIV infection. 7. Subjects with active Hepatitis B and C infection requiring therapy. 8. Subjects with active infection of tuberculosis. 9. History of organ transplantation. 10. Unresolved toxicities from prior anti-cancer therapy. 11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies. 12. Subjects with major cardiovascular diseases. 13. History of alcoholism or drugs abuse. 14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	from the day of first dose to 90 days after last dose of CS1003

Countries

China

Outcome results

None listed