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CompletedLast updated: 7 February 2024

This phase Ia/Ib trial is evaluating how safe, tolerable and effective a new targeted therapy is, given alone or in combination with another targeted therapy, in patients with advanced cancerA Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors

Clinical summary

Summary

This is a dose escalation and expansion trial. Eligible patients will be randomised to receive intravenous CS1002 as a monotherapy or in combination with a fixed 200mg dose of CS1003.

Conditions

This trial is treating patients with advanced cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

C-Stone Pharmaceuticals

Scientific Title

A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors

Eligibility

Inclusion

  1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
  2. ECOG performance status of 0 or 1.
  3. Life expectancy ≥12 weeks.
  4. Subjects must have adequate organ function
  5. Use of effective contraception

Exclusion

  1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
  2. Subjects with active autoimmune diseases or history of autoimmune diseases.
  3. Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS1002.
  4. Has received prior therapy with an anti-CTLA-4 agent.
  5. Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.
  6. Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS1002.
  7. Receipt of live vaccine within 28 days prior to the first dose of CS1002
  8. Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1002.
  9. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
  10. Known history of HIV.
  11. Subjects with active Hepatitis B or C infection
  12. Subjects with active tuberculosis infection.
  13. Subjects with an active infection requiring systemic therapy.
  14. History of organ transplantation.
  15. History of alcoholism or drugs abuse.
  16. History of severe hypersensitivity reactions to other mAbs.
  17. Subjects with major cardiovascular diseases.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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