Actively Recruiting
A Phase 1/2 Study of BIO-106 Alone or With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
Led by BiOneCure Therapeutics Inc. · Updated on 2022-07-19
332
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating BIO-106, a new antibody-drug conjugate targeting Trop-2, alone and combined with pembrolizumab, a PD-1 blocking antibody, in patients with advanced solid tumors or cancers that have progressed despite standard treatments or cannot tolerate them. This open-label Phase 1/2 trial aims to find the best tolerated dose in Phase 1 and evaluate preliminary effectiveness in Phase 2 for patients with significant unmet medical needs. In Phase 1, patients receive increasing doses of BIO-106 alone or with pembrolizumab to determine the maximum tolerated dose or recommended dose for Phase 2. Phase 2 involves dose expansion to assess anti-tumor activity using measures like response rates and survival. Participants receive treatments according to their assigned group, and dosing schedules follow the study design without blinding or placebo. Participants undergo regular monitoring for adverse events, dose-limiting toxicities, and antibody formation against BIO-106. Effectiveness is measured by tumor response, disease control, duration of response, progression-free survival, and overall survival over one to two years. Safety and pharmacokinetics data are collected throughout, with close evaluation of serious events and special interest adverse events. The study expects to last until April 2027.
CONDITIONS
Brief Title
A Study in Patients With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with locally advanced or metastatic solid tumors confirmed by tissue analysis
- Disease progression after standard treatment or inability to tolerate standard treatment
- Measurable disease by RECIST v.1.1 or bone-only disease
- ECOG performance status of 0 or 1
You will not qualify if you...
- History of severe allergic reaction to pembrolizumab or other monoclonal antibodies
- Clinically significant heart disease or impaired cardiac function
- Infection with HIV, active hepatitis B or C
- Active COVID-19 infection
- Untreated central nervous system tumors or brain metastases
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year in Phase 1; up to 2 years in Phase 2
Participants receive escalating doses of BIO-106 alone or in combination with pembrolizumab to define the maximum tolerated dose and to evaluate preliminary efficacy in advanced cancers.
Visits scheduled regularly during dosing and assessments
Duration - Up to 2 years after treatment
Participants are monitored for safety and efficacy outcomes including adverse events and anti-tumor activity after treatment ends.
Periodic visits for assessments depending on participant status
Trial Site Locations
Total: 3 locations
1
NEXT Oncology Austin
Austin, Texas, United States, 78758
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
B
BiOneCure Therapeutics Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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