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BGC515 for Cancer

Phase 1

Recruiting

Research Sponsored by BridGene Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1

Be older than 18 years old

Must not have

Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 3 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety, side effects, how the drug moves through the body, and how well it works of a drug called BGC515 in cancer patients with solid tumors.

Who is the study for?

This trial is for patients with advanced solid tumors, including specific types such as Epithelioid Hemangioendothelioma and Mesothelioma. Participants must meet certain health standards to be eligible.

What is being tested?

The study tests BGC515 capsules given daily in 3-week cycles to see how safe they are, how the body processes them, and if they work against solid tumors.

What are the potential side effects?

Since this is a Phase I trial primarily focused on safety and dosage levels, specific side effects of BGC515 will be identified during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used TEAD inhibitors before.

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I am not pregnant or breastfeeding.

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I am not allergic to BGC515 or its ingredients.

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I do not have severe or unstable illnesses or brain metastases causing symptoms.

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I have a serious heart condition as described in the study details.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLTs)

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

Objective response rate (ORR)

+1 more

Secondary study objectives

Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t).

Half-life (t1/2).

Peak concentration (Cmax).

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

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 II: Dose EscalationExperimental Treatment1 Intervention

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).

0 / 6Eligibility criteria met