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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452160
Other study ID # BGC515-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 2024
Est. completion date December 2027

Study information

Verified date June 2024
Source BridGene Biosciences Inc.
Contact BridGene Biosciences
Phone 408-498-8127
Email clinical@bridgenebiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 103
Est. completion date December 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BGC515
Capsules for oral administration

Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
BridGene Biosciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) and serious adverse events (SAEs). 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. Through study completion, approximately 1 year.
Primary Dose-limiting toxicities (DLTs) DLT refers to the pre-specified AEs that occurred within 24 days after the first dose of study drug. Within 24 days after the first dose of study drug.
Primary Objective response rate (ORR) 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. Through study completion, approximately 3 years.
Primary Progress-free survival(PFS) 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. Through study completion, approximately 3 years.
Secondary Peak concentration (Cmax). Cmax of BGC515 in plasma. Multiple time points, up to approximately 1 year.
Secondary Time to peak concentration (Tmax). Tmax of BGC515 in plasma. Multiple time points, up to approximately 1 year.
Secondary Half-life (t1/2). t1/2 of BGC515 in plasma. Multiple time points, up to approximately 1 year.
Secondary Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t). (AUC0-t) of BGC515 in plasma. Multiple time points, up to approximately 1 year.
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