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Completed

NCT Number: NCT03312842

A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

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 CS1001 in subjects with advanced solid tumors.

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Key information

Conditions

Advanced Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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 six months 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.
  • 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 [email protected]

Treatment and study plan

CS1001

Drug

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.

Primary outcomes

  1. 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

  2. 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

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-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 18, 2017
Registry last updated
May 26, 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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