A Phase 1/2 Study in Patients With Advanced Cancers

• Status: Recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BiOneCure Therapeutics Inc.
• Treatments: Pembrolizumab

Criteria

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.