Study on SAR445877 for Adults with Advanced Solid Tumors

Sponsor: Sanofi

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05584670

Provider View

This clinical trial is testing a new drug, SAR445877, to see if it is safe and effective for adults with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body. The study will explore SAR445877 alone and in combination with other cancer treatments.

Patient Parameters

Program Overview

This study is in two parts. The first part will find the best dose of SAR445877, given either every two weeks or weekly, alone or with other cancer treatments. The second part will test the safety and effectiveness of SAR445877 at two recommended doses, both alone and with other treatments, in different types of cancer. About 285 participants will join, with 75 in the first part and up to 210 in the second part.

Description

Participants will go through a screening period of up to 28 days. During the treatment period, they will receive SAR445877 until their cancer worsens, they experience unacceptable side effects, they choose to stop, or other criteria for stopping are met. After treatment ends, a follow-up visit will occur about 30 days later. Participants will be monitored until their cancer progresses, they start a new treatment, they pass away, or they withdraw from the study.

Eligibility Criteria

Inclusion Criteria

  • Part 1: Adults with advanced solid tumors that cannot be surgically removed or have spread, and for whom no standard treatment is available or suitable.
  • Part 2:
    • Cohorts A1 and A2: Adults with metastatic non-small cell lung cancer.
    • Cohort B: Adults with advanced liver cancer, confirmed by tests or specific criteria.
    • Cohorts C1 and C2: Adults with advanced stomach cancer or certain types of gastroesophageal cancer, with specific test results.
    • Cohorts E1, E2, and E3: Adults with advanced colorectal cancer, with specific genetic markers.
  • Must have at least one measurable tumor.
  • Must be able to provide informed consent.

Exclusion Criteria

  • Poor overall health with a performance status of 2 or higher.
  • Life expectancy of 3 months or less.
  • For liver cancer patients in Part 2: Certain liver function scores.
  • Other active cancers within the last 2 years.
  • Active brain or spinal cord cancer spread.
  • Severe past immune-related side effects from certain treatments.
  • Need for ongoing high-dose steroid treatment.
  • Significant heart or blood vessel disease in the last 6 months.
  • Recent significant autoimmune disease requiring treatment.
  • History of lung disease or non-infectious lung inflammation in the last 3 years.
  • Organ transplant requiring immune suppression.
  • Uncontrolled or active HIV, hepatitis B, or hepatitis C infection.

Note: Other criteria may apply. This information is not exhaustive.

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