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NCT Number: NCT06452160

A Study of BGC515 Capsules in Subjects 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ileana Gutierrez

CONTACT

[email protected]

713-563-2158

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGC515

Drug

Capsules for oral administration

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Peak concentration (Cmax).

    Time frame: Multiple time points, up to approximately 1 year.

    Cmax of BGC515 in plasma.

  2. Time to peak concentration (Tmax).

    Time frame: Multiple time points, up to approximately 1 year.

    Tmax of BGC515 in plasma.

  3. Half-life (t1/2).

    Time frame: Multiple time points, up to approximately 1 year.

    t1/2 of BGC515 in plasma.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BridGene Biosciences

CONTACT

[email protected]

408-498-8127

Sponsors and collaborators

Lead sponsor

BridGene Biosciences Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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