A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors

Use of immunotherapy, biological therapy, cytokine therapy \< 21 days prior to the first dose of study drug.

Use of immunomodulating agents \< 21 days prior to the first dose of study drug.

Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy \< 14 days prior to the first dose of study drug.

Anti PD-L1 or anti PD-1 therapy \< 6 weeks prior to the first dose of study drug.

Radiotherapy within 14 days before the start of trial treatment (prior diagnostic biopsy is permitted), with the exception of palliative radiation as described: patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate; The lesion should be causing some signs or symptoms (e.g., tumor-related pain), for which radiation is indicated per the physician's standard clinical practice.

Use of any investigational drug or have major surgery within 28 days before the start of trial treatment

Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required systemic immunosuppressive treatments.

Systemic therapy with immunosuppressive agents including corticosteroids within 14 days before the start of trial treatment with the exception of corticosteroid replacement therapy for adrenal insufficiency

Rapidly progressive disease which, in the opinion of Investigator, may predispose to inability to tolerate treatment or trial procedure.

History or clinical evidence of central nervous system primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, demonstrated no progression at least 1 months, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening - Participants with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry.

Receipt of any organ transplantation including hematopoietic cell transplantation.

Has a paraneoplastic syndrome of autoimmune nature.

History of interstitial lung disease or severe obstructive pulmonary disease.

Clinically significant cardiovascular/cerebrovascular disease.

QTc(F) interval \> 450 ms for men or \> 470 ms for women)

Left ventricular ejection fraction (LVEF) \< 50% as measured by an echocardiogram (ECHO).

Active infection requiring therapy.

Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding.

Pregnant or breast-feeding women

Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) of anaphylaxis

Vaccine administration within 4 weeks of investigational drug administration.

Vaccination with live vaccines while on trial is prohibited. Administration of inactivated vaccines like inactivated influenza vaccines is allowed. COVID-19 vaccines are approved to be administered prior to KD033 (SAR445710) administration and during the treatment phase, however, it is preferred to not vaccinate during the 28-day DLT period.

What this study is about