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Trial Title:
A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
NCT ID:
NCT06452160
Condition:
Mesothelioma
Epithelioid Hemangioendothelioma(EHE)
Solid Tumor
Conditions: Official terms:
Mesothelioma
Hemangioendothelioma
Hemangioendothelioma, Epithelioid
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGC515
Description:
Capsules for oral administration
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ileana Gutierrez
Phone:
713-563-2158
Email:
ilgutierrez@mdanderson.org
Start date:
June 27, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
BridGene Biosciences Inc.
Agency class:
Industry
Source:
BridGene Biosciences Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06452160
