A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

BridGene Biosciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor; Mesothelioma; Epithelioid Hemangioendothelioma(EHE)

Treatments: Drug: BGC515

Study type: Interventional

Funder types: Industry

Identifiers

NCT06452160

BGC515-101

Details and patient eligibility

About

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.

Enrollment: 103 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

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).

Treatment:

Drug: BGC515

Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: BGC515