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Phase II Biomarker Study of BND-22 and Cemiplimab in Solid Tumors

This study is looking at how two drugs, SAR444881 and cemiplimab, work together in people with certain advanced or metastatic solid tumors (cancers that form solid masses). The main goal is to find "biomarkers" (biological signs in your body) that might show how these drugs affect the tumor, predict if the treatment will work, or show why it might not work. You could be eligible if you are at least 18 years old and have non-small cell lung cancer (NSCLC), or certain types of colorectal or ovarian cancer. For NSCLC, you must have had prior treatment. The study will also check how safe and effective the combination of SAR444881 and cemiplimab is. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events (side effects) will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06651593

Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:SAR444881Cemiplimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Solid Tumors

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NCT06651593

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Md Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aung Naing, Md · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Aung Naing, Md
[email protected]
713-563-3885
Email the study team

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Eligibility criteria

Inclusion

Cohort 1: NSCLC
Cohort 2: MSS CRC and ovarian cancer 4. Prior 10 therapy exposure (Cohort 1 only). 5. Anti-PD-1/PD-L1 na"i"ve (Cohort 2 only). 6. One lesion suitable for repeat biopsy without significant risk to the patient. 7. Measurable disease per the Response Evaluation Criteria in Solid Tumors. Measurable disease should not be the lesion needed for repeat biopsy. 8. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1. 9. Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
Hemoglobin \>9.0 g/dl (red blood cell/plasma transfusion is not allowed within 2 weeks prior to screening assessment erythropoiesis-stimulating agents/colony- stimulating factors are not allowed within 1 week prior to screening assessment)
Absolute neutrophil count 1500/ml (growth factors are not allowed within 2 weeks prior to screening assessment)
Platelets 75,000/ml
Total bilirubin $1.5 x institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is $3 x ULN.
Aspartate transaminase/ALT $2.5 x institutional ULN. Transaminases up to 5 x ULN in the presence of liver metastases.
Serum creatinine $1.5 x ULN OR measured or calculated creatinine clearance (CrCI; glomerular filtration rate can also be used in place of creatinine or CrCI) 30 ml/min for patients with creatinine levels \>1.5 x institutional ULN (CrCI should be calculated per institutional standard)
For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time :51.5 x ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen. 10. Life expectancy 3 months. 11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening. 12. WOCBP must agree to use adequate contraception for the duration of study participation and for 10 months after completion of study treatment. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a post- menopausal state ( 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mi..illerian agenesis). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 13. Male participants of childbearing potential must agree to use adequate contraception for the duration of study participation and for 7 months after completion of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time. 14. Willing to undergo mandatory biopsies and blood collections as required by the study.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0