Phase II Study of SAR444881 and Cemiplimab in Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06651593

Provider View

This clinical trial is exploring how the drug SAR444881, alone or with cemiplimab, works in people with solid tumors. The study aims to find biomarkers that might predict how well the treatment works and its safety.

Patient Parameters

Program Overview

The purpose of this study is to investigate potential biomarkers that could be linked to the effectiveness of SAR444881, either by itself or when combined with cemiplimab, in treating solid tumors. Researchers are looking to see if these biomarkers can predict how well patients respond to the treatment, how long they survive without the disease getting worse, and any resistance to the treatment.

Description

The main goals of this study are to identify biomarkers that relate to how SAR444881 works alone and with cemiplimab in people with solid tumors. Researchers want to find out if these biomarkers can predict how well patients respond to the treatment, how long they survive without the disease progressing, and any resistance to the treatment. They will measure outcomes like the objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS).

The study also aims to evaluate the effectiveness and safety of the SAR444881 and cemiplimab combination. Researchers will monitor how well the treatment works and any side effects that occur.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and agree to sign a consent form before starting the study.
  • Must be 18 years or older.
  • Have a confirmed diagnosis of locally advanced or metastatic solid tumor, such as non-small cell lung cancer (NSCLC), colorectal cancer, or ovarian cancer.
  • For NSCLC patients, must have had prior therapy.
  • For colorectal and ovarian cancer patients, must not have had prior anti-PD-1/PD-L1 therapy.
  • Must have a tumor that can be biopsied safely.
  • Must have measurable disease that is not the same as the biopsy site.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate organ and bone marrow function based on specific blood tests.
  • Must have a life expectancy of at least 3 months.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 10 months after.
  • Men must agree to use contraception during the study and for 7 months after.
  • Must be willing to undergo biopsies and blood tests as required by the study.

Exclusion Criteria

  • History of severe allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.
  • Active autoimmune diseases, except for certain stable conditions.
  • Need for systemic steroids or immunosuppressive drugs within 14 days before starting the study.
  • Positive test for HIV or active hepatitis B or C infection.
  • Previous organ or stem cell transplant.
  • Known brain or leptomeningeal metastases.
  • Active infection requiring IV antibiotics or other serious illness.
  • Unresolved side effects from previous treatments.
  • Previous treatment with PD-1, PD-L1, or CTLA-4 inhibitors that required stopping due to side effects.
  • Participation in another clinical trial or treatment with investigational drugs.
  • Recent live vaccine within 4 weeks before starting the study.
  • Inadequate recovery time from previous treatments.
  • Prior treatment with ILT2 or ILT4 inhibitors.
  • Another active cancer requiring treatment.
  • Psychiatric or substance abuse issues that interfere with study participation.
  • Inability to comply with study procedures.

Locations

FACILITYZIPCITYSTATE
Md Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.