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

Stopped early · Phase 1/Phase 2

Conditions studied: Cancer, Neoplasm

In brief

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.

Key facts

Study ID

NCT04717375

Run by

Sanofi

People needed

125

Starts

2021-04-11

Expected to finish

2025-07-02

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital- Site Number : 8400003 — Phoenix, Arizona, United States
• City of Hope Comprehensive Cancer Center- Site Number : 8400002 — Duarte, California, United States
• University of Colorado- Site Number : 8400012 — Aurora, Colorado, United States
• Smilow Cancer Center at Yale-New Haven- Site Number : 8400001 — New Haven, Connecticut, United States
• Clermont Oncology Center- Site Number : 8400005 — Clermont, Florida, United States
• Mid Florida Hematology and Oncology Center- Site Number : 8400006 — Orange City, Florida, United States
• Mercy Cancer Center - MercyOne Richard Deming Cancer Center- Site Number : 8400011 — Des Moines, Iowa, United States
• Norton Cancer Institute - Downtown Women's Cancer Center- Site Number : 8400004 — Louisville, Kentucky, United States
• Mayo Clinic Hospital Rochester- Site Number : 8400007 — Rochester, Minnesota, United States
• Investigational Site Number : 1240001 — Barrie, Ontario, Canada
• Investigational Site Number : 1240003 — Sherbrooke, Quebec, Canada
• Investigational Site Number : 3760004 — Haifa, Israel
• Investigational Site Number : 3760005 — Jerusalem, Israel
• Investigational Site Number : 3760001 — Petah Tikva, Israel
• Investigational Site Number : 3760003 — Ramat Gan, Israel
• Investigational Site Number : 3760002 — Tel Aviv, Israel
• Investigational Site Number : 8260003 — London, London, City of, United Kingdom
• Investigational Site Number : 8260002 — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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