Clinical trial NCT06452160: A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mesothelioma
Epithelioid Hemangioendothelioma(EHE)
Solid Tumor
Lead sponsor: BridGene Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Assignment
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs).
timeFrame: Through study completion, approximately 1 year.
measure: Dose-limiting toxicities (DLTs)
timeFrame: Within 24 days after the first dose of study drug.
measure: Objective response rate (ORR)
timeFrame: Through study completion, approximately 3 years.
measure: Progress-free survival(PFS)
timeFrame: Through study completion, approximately 3 years.
Secondary outcomes:
measure: Peak concentration (Cmax).
timeFrame: Multiple time points, up to approximately 1 year.
measure: Time to peak concentration (Tmax).
timeFrame: Multiple time points, up to approximately 1 year.
measure: Half-life (t1/2).
timeFrame: Multiple time points, up to approximately 1 year.
measure: Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t).
timeFrame: Multiple time points, up to approximately 1 year.
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: