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BGC515 for Advanced Solid Tumors

This study is testing a new capsule medicine called BGC515 for people with advanced solid tumors, including mesothelioma and epithelioid hemangioendothelioma (EHE). The main goals are to see how safe BGC515 is, what side effects it might cause, and if it helps shrink tumors. You might be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and have a good general health score (ECOG Performance Score 0 or 1). The study is looking at how many people experience side effects and how many see their tumors respond to the treatment. The current status of this study is unclear.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving) Phase I study. It plans to enroll 103 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects through study completion, which is approximately 1 year. Tumor response will be measured through study completion, approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06452160

A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
BridGene Biosciences Inc.
~103 participants
Updated 2024-08-09 on ClinicalTrials.gov
What's tested:BGC515

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Measured over Through study completion, approximately 1 year.
+3 more outcomes measured

Conditions

Mesothelioma
Epithelioid Hemangioendothelioma(EHE)
Solid Tumor

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NCT06452160

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

BridGene Biosciences
[email protected]
408-498-8127
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs).Through study completion, approximately 1 year.

    AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. AE evaluation will be based on laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram, etc.

  • Dose-limiting toxicities (DLTs)Within 24 days after the first dose of study drug.

    DLT refers to the pre-specified AEs that occurred within 24 days after the first dose of study drug.

  • Objective response rate (ORR)Through study completion, approximately 3 years.

    Defined as the percentage of participants having complete response (CR) or partial response (PR). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.

  • Progress-free survival(PFS)Through study completion, approximately 3 years.

    Defined as the time interval between the first dose of the treatment and the first documented disease progression or death due to any cause (whichever occurs first). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.