A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

NCT06452160 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGC515-101
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events (AEs) and serious adverse events (SAEs).

  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)

  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)

  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)

  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 Outcomes (4)

• Peak concentration (Cmax).

  Multiple time points, up to approximately 1 year.

• Time to peak concentration (Tmax).

  Multiple time points, up to approximately 1 year.

• Half-life (t1/2).

  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).

  Multiple time points, up to approximately 1 year.

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Dose Expansion

EXPERIMENTAL

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

Interventions

BGC515 DRUG

Capsules for oral administration

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BridGene Biosciences Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Mesothelioma; Hemangioendothelioma, Epithelioid

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Hemangioendothelioma; Hemangioma; Neoplasms, Vascular Tissue

Central Study Contacts

BridGene Biosciences

CONTACT

408-498-8127; clinical@bridgenebiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)