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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: BMS-906024

Study type: Interventional

Funder types: Industry

Identifiers

NCT01292655

CA216-001

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 4 patient groups

Arm A1 (Escalation): BMS-906024

Experimental group

Description:

BMS-906024 solution intravenously as specified

Treatment:

Drug: BMS-906024

Arm A2 (Expansion): BMS-906024

Experimental group

Description:

BMS-906024 solution intravenously as specified

Treatment:

Drug: BMS-906024

Arm B1 (Escalation): BMS-906024

Experimental group

Description:

BMS-906024 solution intravenously as specified

Treatment:

Drug: BMS-906024

Arm B2 (Expansion): BMS-906024

Experimental group

Description:

BMS-906024 solution intravenously as specified

Treatment:

Drug: BMS-906024