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A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Triple Negative Breast Cancer

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ABBV-221

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Oncology, Cancer, Solid Tumor types likely to exhibit elevated levels of Epidermal Growth Factor Receptor, Solid Tumors

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
Has an archived, diagnostic tumor tissue available for analysis.
Has adequate hematologic, renal, cardiac and hepatic function.
Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.

Exclusion Criteria:

Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
History of major immunologic reaction to any IgG containing agent.
Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

Sites / Locations

Massachusetts General Hospital
Dana-Farber Cancer Institute
South Texas Accelerated Research Therapeutics
Fundacion Jimenez Diaz
Hosp Univ Madrid Sanchinarro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Adverse event monitoring will be performed during the study

Maximum Plasma Concentration (Cmax) of ABBV-221

The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval.

Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-221

The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.

Maximum tolerated dose of ABBV-221

The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

Area Under the Plasma Concentration-time Curve of ABBV-221

The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.

Recommended Phase 2 dose of ABBV-221

If a maximum tolerated dose (MTD) is reached, the recommended Phase 2 dose (RPTD) of ABBV-221 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.

Secondary Outcome Measures

Assess the effect of systemic ABBV-221 administration on QT prolongation

ECG parameters will be descriptively summarized, and the relationship between change of baseline of QT interval corrected for heart rate and concentration of three analytes will be explored.

Objective Response Rate (ORR)

ORR is the proportion of participants with objective response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (complete or partial objective response) will be calculated for all dosed participants with at least one measurable lesion at baseline.

Full Information

NCT ID

NCT02365662

First Posted

February 5, 2015

Last Updated

March 28, 2018

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02365662

Brief Title

A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Official Title

A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Safety

Study Start Date

January 9, 2015 (Actual)

Primary Completion Date

March 15, 2018 (Actual)

Study Completion Date

March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Colorectal Carcinoma, Glioblastoma Multiforme

Keywords

Oncology, Cancer, Solid Tumor types likely to exhibit elevated levels of Epidermal Growth Factor Receptor, Solid Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Intervention Type

Drug

Intervention Name(s)

ABBV-221

Intervention Description

ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Adverse event monitoring will be performed during the study

Time Frame

Measured for approximately 4 years

Title

Maximum Plasma Concentration (Cmax) of ABBV-221

Description

The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval.

Time Frame

Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years).

Title

Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-221

Description

The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.

Time Frame

Title

Maximum tolerated dose of ABBV-221

Description

The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

Time Frame

Up to 2 years from first dose of study drug.

Title

Area Under the Plasma Concentration-time Curve of ABBV-221

Description

The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.

Time Frame

Title

Recommended Phase 2 dose of ABBV-221

Description

Time Frame

1 day of study drug administration within the 21-day cycle at the designated cohort dose

Secondary Outcome Measure Information:

Title

Assess the effect of systemic ABBV-221 administration on QT prolongation

Description

ECG parameters will be descriptively summarized, and the relationship between change of baseline of QT interval corrected for heart rate and concentration of three analytes will be explored.

Time Frame

At Days 1, 2, 3, 5, 8 of Cycle 1; Day 1 of every cycle starting at Cycle 2, and Final Visit (approximately 2 years from first dose of study drug)

Title

Objective Response Rate (ORR)

Description

Time Frame

At screening; at the end of Cycle 2 and the end of every 3 cycles for approximately 2 years from first dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2. Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme). Has an archived, diagnostic tumor tissue available for analysis. Has adequate hematologic, renal, cardiac and hepatic function. Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy. Exclusion Criteria: Previously received an EGFR-directed monoclonal antibody within the past 4 weeks. Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events. History of major immunologic reaction to any IgG containing agent. Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

South Texas Accelerated Research Therapeutics

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hosp Univ Madrid Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

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