Actively Recruiting
A Phase I Study Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
Led by BridGene Biosciences Inc. · Updated on 2024-08-09
103
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I open-label clinical trial to study BGC515 capsules in patients with advanced solid tumors, including mesothelioma and epithelioid hemangioendothelioma. The trial aims to evaluate the safety, tolerability, how the drug is processed in the body, and preliminary effectiveness of BGC515 when given once daily in 3-week cycles. This early-phase study will help determine the best dose for future treatment evaluations. Participants will take BGC515 capsules orally once a day in 21-day cycles. The study has two main parts: a dose escalation phase where increasing doses are tested to find the highest tolerable dose and recommended dose for further study, followed by a dose expansion phase where the drug is given at that determined dose to patients with specific tumor types or tumors with certain molecular features. Treatment continues in cycles as long as it is safe and effective. During the study, participants will be closely monitored for side effects and drug levels in the blood at various time points up to about one year. Researchers will measure adverse events, dose-limiting toxicities, response rates, and progression-free survival over approximately three years. The study also tracks how the drug is absorbed and cleared from the body. Participants will undergo regular assessments and safety checks throughout their involvement, which may last several years.
CONDITIONS
Brief Title
A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- Male or female aged 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
- Histologically or cytologically confirmed locally advanced or metastatic mesothelioma, epithelioid hemangioendothelioma, or other advanced solid tumors
- Disease progression or intolerance after standard treatment, refusal of standard treatment, or no access to standard treatment
- At least one measurable tumor lesion
You will not qualify if you...
- Previous or current use of TEAD inhibitors
- Insufficient wash-out period from prior therapies as defined in the protocol
- Severe or unstable systemic diseases
- Unstable or symptomatic central nervous system metastases
- Clinically significant cardiovascular disease
- Pregnant or breastfeeding women
- Hypersensitivity to BGC515 or its ingredients
- Study staff members or relatives involved in this clinical trial
- Serious systemic diseases or lab abnormalities that make participation unsuitable at investigator's discretion
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 approximately 3 years
Participants receive BGC515 capsules orally once daily in 21-day cycles during dose escalation and dose expansion to evaluate safety and effectiveness.
Repeated visits every 21 days for dosing and assessments
Duration - Through study completion, approximately 3 years
Participants are monitored for adverse events, response to treatment, and progression-free survival after treatment ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
BridGene Biosciences
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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