A Study of ABT-806 in Subjects With Advanced Solid Tumor Types

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255657
• Other study ID #: M11-847
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2010
• Last updated: November 17, 2017
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.

• Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.

• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

• Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

• Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .

Exclusion Criteria:

• Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.

• Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.

• Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.

• Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.

• Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• ABT-806
ABT-806 will be administered by intravenous infusion.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 54056	Baltimore	Maryland
United States	Site Reference ID/Investigator# 41931	Boston	Massachusetts
United States	Site Reference ID/Investigator# 43422	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Number of subjects with adverse events and/or dose-limiting toxicities)	Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)	At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)
Primary	Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort	Assay for ABT-806	Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit
Primary	Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort	Assay for ABT-806	Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up
Secondary	Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort	Assay for Anti-drug antibody against ABT-806	Week 1, 3, 7, 11, 15, 19, 23 and Final Visit
Secondary	QT assessment	Triplicate ECGs	Week 1, 7, 13, and 30 day follow-up visit
Secondary	Infusion rate evaluation (Expanded Safety Cohort)	Two infusion times explored	Every other week
Secondary	Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort	Assay for Anti-drug antibody against ABT-806	Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up