Study on SAR444881 Alone and with Other Treatments for Advanced Solid Tumors

Sponsor: Sanofi

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04717375

Provider View

This clinical trial is testing a new drug, SAR444881, both by itself and in combination with other treatments, to see if it can help patients with advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body.

Patient Parameters

Program Overview

The study is for patients with advanced cancer that cannot be surgically removed or has spread, and who have not responded to standard treatments or are not suitable for them. It has two main parts: Part 1 focuses on finding the right dose of SAR444881, either alone or with other drugs like pembrolizumab and cetuximab. Part 2 aims to optimize and expand the dosing, including combinations with other drugs like carboplatin and pemetrexed. The study will use randomization in some parts to compare different doses and combinations.

Description

The study is expected to last about 34 months for the dose escalation phase (Part 1) and about 28 months for the dose optimization and expansion phase (Part 2).

In Part 1, the study will test SAR444881 alone and in combination with pembrolizumab or cetuximab to find the best dose. In Part 2, the study will further refine the dosing and test SAR444881 with additional drugs like carboplatin and pemetrexed. Some parts of the study will involve randomization to compare different treatment approaches.

Eligibility Criteria

Inclusion Criteria

  • Have advanced cancer that cannot be removed by surgery or has spread, and have not responded to standard treatments or are not suitable for them.
  • Have a confirmed diagnosis of cancer.
  • Have measurable disease according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function based on lab tests.
  • For Part 1: Have one of the following types of cancer: breast, cervical, colorectal, esophageal, gastric, head and neck, liver, gallbladder, bile duct, lung, kidney, skin, pancreatic, ovarian, or bladder cancer.
  • For Part 2: Have one of the following types of cancer: head and neck, gastric, lung, colorectal, or bile duct cancer.

Exclusion Criteria

  • Have an active or suspected autoimmune disease.
  • Require treatment with steroids or other immune-suppressing medications.
  • Have cancer that has spread to the brain or spinal fluid.
  • Have a history of HIV.
  • For non-liver cancer patients: have active hepatitis B or C; for liver cancer patients: have untreated active hepatitis B or both hepatitis B and C.
  • Have had a solid organ or stem cell transplant.
  • Have had severe side effects from previous immune therapy.
  • Have had severe side effects from cetuximab or similar drugs (for certain parts of the study).
  • Have unstable heart disease within the last 6 months.
  • Have had major surgery within 4 weeks before starting the study.
  • Have received certain cancer treatments or investigational drugs recently.
  • Have had a live vaccine within 28 days before starting the study.

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