Actively Recruiting
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.
CONDITIONS
Official Title
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent before starting the study
- Age 18 years or older
- Histologically confirmed locally advanced or metastatic solid tumor: NSCLC, MSS colorectal cancer, or ovarian cancer
- Prior therapy exposure for NSCLC cohort
- Anti-PD-1/PD-L1 therapy naive for colorectal and ovarian cancer cohort
- At least one lesion suitable for repeat biopsy without significant risk
- Measurable disease by Response Evaluation Criteria in Solid Tumors, excluding the biopsy lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function within 28 days before starting treatment
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative pregnancy test at screening and agree to use contraception during and for 10 months after study treatment
- Male participants of childbearing potential must agree to use contraception during and for 7 months after study treatment and refrain from sperm donation
- Willingness to undergo mandatory biopsies and blood collections as required
You will not qualify if you...
- History of allergic reactions to drugs similar to study drugs
- Pregnant or breastfeeding
- Active autoimmune disease requiring systemic treatment; some treated or mild autoimmune conditions allowed
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before treatment start
- Known HIV infection or AIDS
- Acute hepatitis B or C infection; chronic infection with undetectable viral load allowed
- Previous solid organ or allogeneic hematopoietic stem cell transplant
- Known brain or leptomeningeal metastases
- Active infection needing IV antibiotics or uncontrolled illness requiring hospitalization
- Unresolved toxicities from prior therapy not improved to grade 1 or baseline, except certain endocrinopathies and mild neuropathy
- Prior PD-1, PD-L1, or CTLA-4 inhibitor treatment leading to permanent discontinuation or systemic immunosuppression for immune-related adverse events (NSCLC cohort only)
- Use of other investigational agents
- Recent live vaccine within 4 weeks before treatment or planned during study or 5 months after last dose
- Inadequate washout from prior therapies as specified
- Prior treatment with ILT2 or ILT4 inhibitors
- Additional active malignancies requiring treatment, except some treated skin cancers and in situ cervical cancer
- Psychiatric or substance abuse disorders interfering with study compliance
- Inability to comply with study and follow-up procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Aung Naing, Md
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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