Clinical Trial 23918

• Overview

  Study Title:

  A Phase I /II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Participants with Advanced Solid Tumors

  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.

  Objective:

  Part I: Dose Escalation Phase (Phase I) Primary Objectives -To evaluate the safety and tolerability of BGC515 Capsules in participants with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations. Other pathway alterations may be allowed after discussion with the medical monitor. -To explore the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Part II: Dose Expansion Phase (Phase II) Primary Objectives -To further evaluate the safety and tolerability of BGC515 Capsules in participants with MM, EHE, glioblastoma, or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations or other pathway alterations allowed by medical monitor upon discussion, so as to determine the recommended phase 2 dose (RP2D). -To evaluate the preliminary efficacy of BGC515 Capsules in participants with MM, EHE, glioblastoma, or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations or other pathway alterations allowed by medical monitor upon discussion. Part I: Dose Escalation Phase (Phase I) Secondary objectives: -To evaluate the pharmacokinetics (PK) of BGC515 Capsules in participants with MM, EHE, or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations. Other pathway alterations may be allowed after discussion with the medical monitor. -To preliminarily evaluate the efficacy of BGC515 Capsules in participants with MM, EHE, or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations. Other pathway alterations may be allowed after discussion with the medical monitor. Part II: Dose Expansion Phase (Phase II) Secondary Objectives: -To evaluate the PK of BGC515 Capsules in participants with MM, EHE, glioblastoma, or other advanced solid tumors with Hippo pathway abnormalities, including NF1/2, FAT1, YAP, TAZ, LATS1/2 and MST1/2 alterations or other pathway alterations allowed by medical monitor upon discussion.

• Treatments

  Therapies:

  TEAD inhibitor

  Medications:

  BGC515 ()

• Inclusion Criteria

  Key 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

  Key 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.

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