Recruiting
Phase 1

BGC515

Sponsor:

BridGene Biosciences Inc.

Code:

NCT06452160

Conditions

Mesothelioma

Epithelioid Hemangioendothelioma(EHE)

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGC515

Study Details

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.

Conditions

Mesothelioma

Epithelioid Hemangioendothelioma(EHE)

Solid Tumor

Study ID

NCT06452160

Start date

Jun 27, 2024

Status verified date

Aug, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

103 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

BGC515

Capsules for oral administration

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BridGene Biosciences

408-498-8127clinical@bridgenebiosciences.com

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ileana Gutierrez

713-563-2158ilgutierrez@mdanderson.org

More Information

Sponsor

BridGene Biosciences Inc.

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BridGene Biosciences Inc. on 2024-08-09.