A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Launched by BRIDGENE BIOSCIENCES INC. · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BGC515 to see how safe it is and how well it works for patients with advanced solid tumors, including mesothelioma and epithelioid hemangioendothelioma. The trial will give participants BGC515 once a day for three weeks at a time, and researchers will closely monitor them for any side effects and how their bodies process the medication.

To be eligible for this trial, participants must be at least 18 years old, have a life expectancy of at least 12 weeks, and have certain types of cancer that have either not responded to standard treatments or for which standard treatments are not available. Participants should have at least one measurable tumor and must not have severe health issues or certain other conditions that could make participation unsafe. If you or a loved one meet these criteria and are interested, you can expect regular check-ups and support from the research team throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion 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 disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care
• • 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 pathway abnormalities, who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care
• • At least one measurable lesion
• Exclusion Criteria:
• • 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.