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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Part I: Dose Escalation Phase

Primary Objectives:

To evaluate the safety and tolerability of BGC515 Capsules in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.
To explore the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD).

Secondary Objectives:

To evaluate the pharmacokinetics (PK) of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.
To preliminarily evaluate the efficacy of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.

Part II: Dose Expansion Phase

Primary Objectives:

To further evaluate the safety and tolerability of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation, so as to determine the recommended phase 2 dose (RP2D).
To evaluate the preliminary efficacy of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.

Secondary Objectives:

To evaluate the PK of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices