A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

August 7, 2024 updated by: BridGene Biosciences Inc.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

103

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
BGC515 Capsules will be administered orally in 21 day cycles, once daily (QD). Patients will be enrolled into escalating dose levels during the Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE).
Drug: BGC515
Capsules for oral administration
Experimental: Dose Expansion
BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.
Drug: BGC515
Capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Time Frame: Through study completion, approximately 1 year.
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.
Dose-limiting toxicities (DLTs)
Time Frame: Within 24 days after the first dose of study drug.
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.
Objective response rate (ORR)
Time Frame: Through study completion, approximately 3 years.
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.
Progress-free survival(PFS)
Time Frame: Through study completion, approximately 3 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax).
Time Frame: Multiple time points, up to approximately 1 year.
Cmax of BGC515 in plasma.
Multiple time points, up to approximately 1 year.
Time to peak concentration (Tmax).
Time Frame: Multiple time points, up to approximately 1 year.
Tmax of BGC515 in plasma.
Multiple time points, up to approximately 1 year.
Half-life (t1/2).
Time Frame: Multiple time points, up to approximately 1 year.
t1/2 of BGC515 in plasma.
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.
(AUC0-t) of BGC515 in plasma.
Multiple time points, up to approximately 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BridGene Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGC515-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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