Status:
TERMINATED
Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Cancer
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 par...
Detailed Description
Estimated Study Duration: Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04717375
Start Date
April 11 2021
End Date
July 2 2025
Last Update
August 7 2025
Active Locations (18)
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1
Mayo Clinic Hospital- Site Number : 8400003
Phoenix, Arizona, United States, 85054-4504
2
City of Hope Comprehensive Cancer Center- Site Number : 8400002
Duarte, California, United States, 91030
3
University of Colorado- Site Number : 8400012
Aurora, Colorado, United States, 80045
4
Smilow Cancer Center at Yale-New Haven- Site Number : 8400001
New Haven, Connecticut, United States, 06511