SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL

Inclusion Criteria

• •Patients must have a histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator do not have a suitable alternative therapy
• •Disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and safely undergo serial tumor biopsies. For patients with castration-resistant prostate cancer, evaluable disease by Prostate Cancer Working Group 3 (PCWG3) will be permitted if serial biopsies (e.g. bone tumor biopsies) are feasible
• •Patients must have previously received a PD-1 or PD-L1 inhibitor-based therapy and must have achieved stable disease (SD) for at least 6 months, or complete remission/partial remission (CR/PR) prior to disease progression (secondary resistance) by radiological assessment by the study investigator. The PD-1 or PD-L1 inhibitor-based therapy must be the immediate line of treatment prior to study enrollment
• •Patients must have adequate functional status as defined by Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• •Absolute neutrophil count (ANC) \>= 1,500 /mcL
• •Platelets \>= 100,000 / mcL
• •Hemoglobin \>= 9.0 g/dL
• •Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 x institutional ULN (creatinine clearance should be calculated per institutional standard)
• •Serum total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \>= 1.5 x ULN
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN OR =\< 5 x ULN for subjects with liver metastases
• •International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN
• •Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN
• •Patients must have discontinued all previous systemic cancer treatments for at least 21 days and recovered from the acute toxic effects of therapy to grade \< 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, excluding persistent grade 2 or higher toxicities determined to be clinically insignificant per the principal investigator (PI) (i.e. alopecia or grade 2 neuropathy). Patients must have discontinued from previous treatments as shown below:
• •* Cytotoxic therapies or targeted agents that are small-molecule inhibitors \>= 3 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* Mitomycin C or nitrosoureas \>= 42 days prior to (study entry/enrollment/first dose of study treatment)
• •* Biologic agents (e.g., antibodies) \>= 3 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* Immunotherapy (e.g., CTLA4, PD-1, PDL1 inhibitors) \>= 3 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* Radiotherapy \>= 4 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* Limited field radiotherapy or palliative radiotherapy \>= 3 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* Major surgery, excluding biopsy: Patients with recent major surgery must have recovered, in the opinion of the investigator, from the toxicity and/or complication from the intervention before starting therapy
• •* Study drug with an investigational product, or non-approved use of a drug or device \>= 3 weeks prior to (study entry/enrollment/first dose of study treatment)
• •* If the patient was treated with an agent with a short half-life, washout can be \< 3 weeks but no shorter than 5 times the half-life
• •Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test at screening and within 2 days prior to receiving first dose of study treatment unless prior tubal ligation (\>= 1 year before screening), total hysterectomy or menopause (defined as 12 consecutive months of amenorrhea). Patients should not become pregnant or breastfeed while on this study. Sexually active patients must agree to use dual contraception for the duration of study participation and for at least 6 months for females and 3 months for males after. Males should not donate sperm during the study and for 3 months after your last dose of study drugs
• •Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures