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A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06452160.