Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

Bristol-Myers Squibb94 enrolled

Overview

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

BMS-906024DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation * Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion * Biopsy accessible tumor (may be waived under certain circumstances) * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) 0-1 * Adequate organ and bone marrow function Exclusion Criteria: * Infection * Elevated triglycerides * Gastrointestinal (GI) disease with increased risk of diarrhea \[e.g. inflammatory bowel disease (IBD)\] * Taking medications known to increase risk of Torsades De Pointes

Locations (8)

Anthony El-Khoueiry, Md

Los Angeles, California, United States

Winship Cancer Institute.

Atlanta, Georgia, United States

Wayne State University

Detroit, Michigan, United States

University Of Mississippi Medical Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

Number of subjects with adverse events as a measure of safety and tolerability

Time frame: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year

Secondary Outcomes

Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1

Time frame: Tumor assessments at least every 8 weeks during treatment period

PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies

Time frame: PD changes from baseline during the first 4-5 weeks of dosing

PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)

Time frame: PK at multiple time points during the first 8 weeks of dosing

PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)

Time frame: PK at multiple time points during the first 8 weeks of dosing

PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)

Time frame: PK at multiple time points during the first 8 weeks of dosing

PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)

Time frame: PK at multiple time points during the first 8 weeks of dosing

PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)

Data from ClinicalTrials.gov

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