RECRUITING

A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Conditions

Mesothelioma Epithelioid Hemangioendothelioma(EHE)Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-06-27

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06452160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

BridGene Biosciences

CONTACT

408-498-8127

clinical@bridgenebiosciences.com

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: BridGene Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-06-27

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Mesothelioma
Epithelioid Hemangioendothelioma(EHE)
Solid Tumor