Advanced solid tumors
Conditions
Interventions
Dose escalation study:Oral administration, once daily for 21 consecutive days
Dose expansion study:Oral administration, once daily, at the recommended dose determined in the dose-escalation study, with a cycle of every 21 days
Sponsors
Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Having signed the written Informed Consent Form. 2. Male or female aged >=18 years. 3. Life expectancy >=12 weeks. 4. Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1. 5. 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. 6. 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. 7. At least one measurable lesion.
Exclusion criteria
Exclusion criteria: 1. Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors. 2. Inadequate wash-out of prior therapies described per protocol. 3. Patients with severe or unstable systemic disease, unstable or symptomatic Central Nervous System (CNS) metastasis. 4. Clinically significant cardiovascular disease as defined in the protocol. 5. Women who are pregnant or breastfeeding. 6. Hypersensitivity to the active pharmaceutical ingredient or any excipient of BGC515. 7. 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. 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Serious Adverse Event;Dose limiting toxicity;Objective response rate;Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration;Time to Maximum Concentration;Terminal Elimination Half-Life;Area under the plasma concentration-time curve from time zero to the last measurable concentration(AUC0-t); | — |
Countries
China
Contacts
Public ContactYu Jinming
Cancer Hospital of Shandong First Medical University
Outcome results
None listed