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Recruiting NCT06452160

A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Phase I Interventional Mesothelioma Epithelioid Hemangioendothelioma(EHE) Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGC515.
Who it may be relevant to
Registry conditions: Mesothelioma, Epithelioid Hemangioendothelioma(EHE), Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug BGC515
    Capsules for oral administration

Primary outcome measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs). [Time frame: Through study completion, approximately 1 year.]
  • Dose-limiting toxicities (DLTs) [Time frame: Within 24 days after the first dose of study drug.]
  • Objective response rate (ORR) [Time frame: Through study completion, approximately 3 years.]
  • Progress-free survival(PFS) [Time frame: Through study completion, approximately 3 years.]
Secondary outcome measures (4)
  • Peak concentration (Cmax). [Time frame: Multiple time points, up to approximately 1 year.]
  • Time to peak concentration (Tmax). [Time frame: Multiple time points, up to approximately 1 year.]
  • Half-life (t1/2). [Time frame: Multiple time points, up to approximately 1 year.]
  • Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t). [Time frame: Multiple time points, up to approximately 1 year.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06452160 · BGC515-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗