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Completed

NCT Number: NCT03809767

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CS1003 monoclonal antibody

Drug

CS1003 will be administered intravenously every 3 weeks.

Primary outcomes

  1. Number of participants with adverse events

    Time frame: from the day of first dose to 90 days after last dose of CS1003

Sponsors and collaborators

Lead sponsor

CStone Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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