A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452160
• Other study ID #: BGC515-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Hemangioendothelioma
• Mesothelioma
• Solid Tumor

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.