Evaluating BGC515 Capsules for Advanced Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
This study is testing a new capsule called BGC515 to see if it can help people with advanced solid tumors that haven't improved with standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BridGene Biosciences Inc. Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06452160 on ClinicalTrials.gov |
What this trial studies
This open-label, dose escalation and expansion Phase I clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGC515 capsules administered once daily in three-week cycles to patients with advanced solid tumors. Participants will include those with locally advanced or metastatic mesothelioma, epithelioid hemangioendothelioma, or other solid tumors who have not responded to standard treatments. The study will involve both a dose escalation phase and a dose expansion phase to gather comprehensive data on the drug's effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have experienced disease progression or treatment intolerability after standard-of-care therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: BridGene Biosciences
- Email: clinical@bridgenebiosciences.com
- Phone: 408-498-8127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.