NCT06452160 A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
| NCT ID | NCT06452160 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | BridGene Biosciences Inc. |
| Condition | Mesothelioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 103 participants in total. It began in 2024-06-27 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06452160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mesothelioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06452160 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06452160 currently recruiting?
Yes, NCT06452160 is actively recruiting participants. Contact the research team at clinical@bridgenebiosciences.com for enrollment information.
Where is the NCT06452160 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06452160 clinical trial?
NCT06452160 is sponsored by BridGene Biosciences Inc.. The trial plans to enroll 103 participants.