Study on S-531011 Alone and with an Immune Checkpoint Inhibitor for Advanced or Metastatic Solid Tumors

Sponsor: Shionogi

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05101070

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, S-531011, both on its own and in combination with another type of cancer treatment called an immune checkpoint inhibitor. The study focuses on patients with advanced or metastatic solid tumors who have limited treatment options.

Patient Parameters

Program Overview

The main goal of this study is to determine how safe and tolerable the new drug S-531011 is for patients with advanced or metastatic solid tumors. Researchers are also trying to find the best dose for future studies. In later parts of the study, they will evaluate how well S-531011 works in shrinking tumors when used at the recommended dose.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic solid tumors that cannot be treated with standard therapies, or are intolerant or unwilling to receive these therapies.
  • Have measurable disease according to specific medical criteria.
  • For Part A: Must have one of the following cancer types: malignant melanoma, head and neck cancer, kidney cancer, bladder cancer, non-small cell lung cancer, triple-negative breast cancer, esophageal cancer, or stomach cancer.
  • For Parts B and C: Must have specific cancer types selected by the study sponsor.
  • Must agree to provide tumor tissue samples for the study.
  • Must have a performance status indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate blood and organ function based on lab tests.
  • Must have a normal heart rhythm as shown by an ECG test.

Exclusion Criteria

  • Have autoimmune or immune-related diseases requiring long-term steroid use.
  • Have lung diseases requiring steroids.
  • Have active infections or recent major infections requiring hospitalization.
  • Have serious heart conditions.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Have a history of immune system deficiencies or organ transplants.
  • Have severe allergies to study drugs or similar medications.
  • Are pregnant, breastfeeding, or trying to become pregnant.
  • Have uncontrolled brain cancer spread.
  • Have another progressing cancer needing treatment in the past 3 years.
  • For Parts A-2 and C: Have had severe side effects from previous similar treatments.
  • Have had recent cancer drug treatments or major surgery.
  • Have had recent radiation therapy or lung inflammation from radiation.
  • Have not recovered from previous treatment side effects.
  • Have had previous treatment with anti-CCR8 antibody.
  • Have had recent blood growth factors or transfusions.
  • Have had a live vaccine recently.

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