Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors
M.D. Anderson Cancer Center
Summary
To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.
Description
Primary Objective * To identify biomarkers: * Related to the mechanism of action of SAR444881 alone and in combination with cemiplimab in participants with solid tumors * Predictive of response/survival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors * To evaluate the association of biomarkers with response/survival and resistance\*: * Objective response rate (ORR) * Clinical benefit rate (CBR) * Progression-free survival (PFS) * Overall survival (OS) Secondary Objectives * To evaluate the efficacy of the SAR444881 and cemiplimab…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures. 2. Age 18 years. 3. Participants with histologically documented locally advanced or metastatic solid tumor: * 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 s…
Interventions
- DrugSAR444881
Given by IV
- DrugCemiplimab
Given by Iv
Location
- Md Anderson Cancer CenterHouston, Texas