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New treatment option for Solid Tumors
Official title Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors
ClinicalTrials.gov ID: NCT06651593
What this study is testing
What is SAR444881?
SAR444881 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures.
- Age 18 years.
- Participants with histologically documented locally advanced or metastatic solid tumor:
- Cohort 1: NSCLC
- Cohort 2: MSS CRC and ovarian cancer
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Participants who are pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Participants with acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be excluded. Participants with chronic HBV or HCV with...
See the full eligibility criteria
- Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures.
- Age 18 years.
- Participants with histologically documented locally advanced or metastatic solid tumor:
- Cohort 1: NSCLC
- Cohort 2: MSS CRC and ovarian cancer
- Prior 10 therapy exposure (Cohort 1 only).
- Anti-PD-1/PD-L1 na"i"ve (Cohort 2 only).
- One lesion suitable for repeat biopsy without significant risk to the patient.
- Measurable disease per the Response Evaluation Criteria in Solid Tumors. Measurable disease should not be the lesion needed for repeat biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of O or 1.
- 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...
- 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...
- 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...
- Life expectancy 3 months.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening.
- 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...
- 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 undergo mandatory biopsies and blood collections as required by the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Participants who are pregnant or breastfeeding.
- Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled...
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Participants with acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be excluded. Participants with chronic HBV or HCV with undetectable viral load will be eligible.
- Previous solid organ or allogeneic HSCT.
- Known brain or leptomeningeal metastases.
- Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
- Unresolved toxicities from prior therapy (defined as having not resolved to :51 Grade or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior...
- Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression due to irAEs (Cohort 1 only).
- Participants who are receiving any other investigational agents.
- Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of study...
- Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 2 weeks or 5 half-lives (whichever is shorter) from...
- Prior treatment with ILT2 or ILT4 inhibitor.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative...
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Inability to comply with the study and follow-up procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.