Status:
RECRUITING
A Study in Patients With Advanced Cancers
Lead Sponsor:
BiOneCure Therapeutics Inc.
Conditions:
Advanced Cancer
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 defi...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT05320588
Start Date
March 25 2022
End Date
April 1 2027
Last Update
July 19 2022
Active Locations (3)
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1
NEXT Oncology Austin
Austin, Texas, United States, 78758
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031