Actively Recruiting
A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
Led by BridGene Biosciences Inc. · Updated on 2024-08-09
103
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.
CONDITIONS
Official 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 of 0 or 1
- Dose escalation phase participants must have histologically or cytologically confirmed locally advanced or metastatic mesothelioma, epithelioid hemangioendothelioma, or other advanced solid tumors with progressive disease or intolerance to standard treatments or lack of access to them
- Dose expansion phase participants must have confirmed locally advanced or metastatic mesothelioma, epithelioid hemangioendothelioma, or other advanced solid tumors regardless of Hippo signaling pathway status, with progressive disease or intolerance to standard treatments or lack of access to them
- At least one measurable lesion
You will not qualify if you...
- Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors
- Inadequate wash-out of prior therapies as specified in the protocol
- Severe or unstable systemic disease or unstable or symptomatic central nervous system (CNS) metastasis
- Clinically significant cardiovascular disease as defined in the protocol
- Women who are pregnant or breastfeeding
- Hypersensitivity to BGC515 or any of its excipients
- Study staff members, their relatives, subordinates of the Investigator, or employees of the Sponsor related to this clinical trial
- Serious systemic diseases, laboratory abnormalities, or other conditions making participation unsuitable at the Investigator's discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
BridGene Biosciences
CONTACT
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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