NCT06452160RecruitingPhase 1
A Study of BGC515 Capsules in Subjects With 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
Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 103 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 27 Jun 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- BridGene Biosciences Inc.
- Diseases
- Mesothelioma
- NCT number
- NCT06452160
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 103
- From 27 Jun 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors
- Inadequate wash-out of prior therapies described per protocol
Other illness
- Patients with severe or unstable systemic disease, unstable or symptomatic Central Nervous System (CNS) metastasis
- Clinically significant cardiovascular disease as defined in the protocol
- Hypersensitivity to the active pharmaceutical ingredient or any excipient of BGC515
Lab values
- 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.
Other
- Women who are pregnant or breastfeeding
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.