A Study in Patients With Advanced Cancers
- Conditions
- Advanced CancerAdvanced Solid TumorOncologyCancer
- Interventions
- Registration Number
- NCT05320588
- Lead Sponsor
- BiOneCure Therapeutics Inc.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 332
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Single agent BIO-106 BIO-106 Escalating doses followed by expansion targeting advanced cancers Combination BIO-106 plus pembrolizumab BIO-106 Escalating doses followed by expansion targeting advanced cancers Combination BIO-106 plus pembrolizumab Pembrolizumab Escalating doses followed by expansion targeting advanced cancers
- Primary Outcome Measures
Name Time Method Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2) 2 years Expansion period
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) 1 year Escalation period
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) up to 21 days Escalation period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) 1 year Escalation period
- Secondary Outcome Measures
Name Time Method PK (Cmax) of BIO-106 - (Phase 1/2) 2 years Escalation and expansion periods
PK (AUC) of BIO-106 - (Phase 1/2) 2 years Escalation and expansion periods
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1) 1 year Escalation Period
Incidence of adverse event of special interest (AESI) - (Phase 2) 2 years Expansion period
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) 2 years Expansion period
Incidence of anti-BIO-106 antibodies - (Phase 1/2) 2 years Escalation and expansion periods
Trial Locations
- Locations (3)
NEXT Oncology Austin
🇺🇸Austin, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology Virginia
🇺🇸Fairfax, Virginia, United States