NCT05320588PHASE1, PHASE2Recruiting
A Study in Patients With Advanced Cancers
BiOneCure Therapeutics Inc.
Start Date
3/25/2022
Completion Date
4/1/2027
Summary
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Detailed Description
This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BIO-106
DRUG
Pembrolizumab
Conditions
Advanced CancerAdvanced Solid TumorCancerOncology
Locations
NEXT Oncology Austin
Austin, Texas 78758
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology Virginia
Fairfax, Virginia 22031
United States