A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors (NCT06452160) | Clinical Trial Compass
RecruitingPhase 1
A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
United States103 participantsStarted 2024-06-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* Stu…
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Timeframe: Through study completion, approximately 1 year.
2
Dose-limiting toxicities (DLTs)
Timeframe: Within 24 days after the first dose of study drug.
3
Objective response rate (ORR)
Timeframe: Through study completion, approximately 3 years.
4
Progress-free survival(PFS)
Timeframe: Through study completion, approximately 3 years.