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New treatment option for Mesothelioma
Official title A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06452160
What this study is testing
What is BGC515?
BGC515 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mesothelioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Having signed the written Informed Consent Form
- Male or female aged ≥18 years
- Life expectancy ≥12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
- Dose escalation phase: Histologically or cytologically confirmed locally advanced or metastatic mesothelioma (MM), epithelioid hemangioendothelioma...
You likely can't join if
- Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors
- Inadequate wash-out of prior therapies described per protocol
- Patients with severe or unstable systemic disease, 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 the active pharmaceutical ingredient or any excipient of BGC515
See the full eligibility criteria
- Having signed the written Informed Consent Form
- Male or female aged ≥18 years
- Life expectancy ≥12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
- Dose escalation phase: Histologically or cytologically confirmed locally advanced or metastatic mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors who have experienced progressive...
- Dose expansion phase: Histologically or cytologically confirmed locally advanced or metastatic MM, EHE, etc. regardless of Hippo signaling pathway abnormalities, or other advanced solid tumors with Hippo signaling...
- At least one measurable lesion
- Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors
- Inadequate wash-out of prior therapies described per protocol
- Patients with severe or unstable systemic disease, 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 the active pharmaceutical ingredient or any excipient of BGC515
- Study staff member or relative of a study staff member directly related to this clinical trial, or a subordinate of the Investigator in this trial or an employee of the Sponsor, though not directly related to this trial
- Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.