Evaluating BGC515 Capsules for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, dose escalation and expansion Phase I clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGC515 capsules administered once daily in three-week cycles to patients with advanced solid tumors. Participants will include those with locally advanced or metastatic mesothelioma, epithelioid hemangioendothelioma, or other solid tumors who have not responded to standard treatments. The study will involve both a dose escalation phase and a dose expansion phase to gather comprehensive data on the drug's effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: BridGene Biosciences
• Email: clinical@bridgenebiosciences.com
• Phone: 408-498-8127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.