A Study in Patients With Advanced Cancers

Summary

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.

Eligibility

Key Inclusion Criteria:

* Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
* Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
* Measurable disease as determined by RECIST v.1.1 or bone only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

* History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.

Impaired cardiac function or history of clinically significant cardiac disease

* Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Active SARS-CoV-2 infection.
* Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Other protocol defined inclusion/exclusion criteria may apply.

Conditions4

Interventions2

Locations3 sites

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