Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

Study on the Effects of an Investigational Medication in Advanced Cancer Patients

Not Recruiting
18 years or above
All
Phase 1/2
456 participants needed

Study Overview

The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 is administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design will be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study is non-randomized except Stage 2 of Sub-Part 2A which will use randomization.

Study Details

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer, Neoplasm
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
  • Histologic confirmation of malignancy
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
  • Participants must have adequate organ function as defined by laboratory tests
  • Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer, cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the skin, pancreatic adenocarcinoma, ovarian cancer or urothelial carcinoma
  • Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric or gastroesophageal junction adenocarcinoma, non-squamous non-small cell lung cancer, non-small cell lung cancer, colorectal carcinoma (CRC) any RAS, and/or Cholangiocarcinoma

Exclusion Criteria:

  • Active, known or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Brain or leptomeningeal metastases
  • Known history of positive test for HIV
  • Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV); HCC patients: untreated active HBV or dual infection with HBV/HCV
  • Participants after solid organ or allogeneic hematopoietic stem cell transplant
  • History of life-threatening toxicity related to prior immune therapy
  • History of life-threatening toxicity related to prior cetuximab or other anti-EGFR antibodies (for Sub-Part 1C)
  • Unstable or deteriorating cardiovascular disease within the previous 6 months
  • Any major surgery within 4 weeks of study drug administration
  • Prior/Concomitant Therapy:
  • Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose
  • Use of other investigational drugs within 28 days
  • Prior treatment with macrophage or natural killer (NK) cells activating therapies
  • Administration of a live attenuated vaccine within 28 days

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Updated on 25 Mar 2025. Study ID: NCT04717375

This study investigates an investigational medication for patients with advanced cancer that cannot be surgically removed or has spread to other parts of the body. The purpose of the study is to explore different dosages and combinations of the investigational medication with other treatments. Participants in this study have cancers such as breast, cervical, colorectal, and several others, and they have not responded to standard treatments.

The study includes two main parts. In the first part, participants receive different doses of the investigational medication, either alone or in combination with other treatments like pembrolizumab and cetuximab. The second part involves optimizing the dose and expanding the study to include more participants. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Patients with advanced cancer that cannot be surgically removed or has spread, and who have not responded to standard treatments, may participate. Eligible participants must have confirmed cancer, measurable disease, and adequate organ function.
  • Study details: Participants will receive the investigational medication alone or with other treatments. The study will explore different doses to find the best one. Some participants may receive a placebo.
  • Study Timelines: The study will last approximately 62 months.