A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Mesothelioma Epithelioid Hemangioendothelioma(EHE) Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

BGC515

Intervention Type DRUG

Capsules for oral administration

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.

Group Type EXPERIMENTAL

BGC515

Intervention Type DRUG

Capsules for oral administration

Interventions

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BGC515

Capsules for oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No