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

NCT01255657 | Completed Phase 1

• 1 other identifier: M11-847
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (4)

• Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort

  Week 1, 3, 7, 11, 15, 19, 23 and Final Visit

• QT assessment

  Week 1, 7, 13, and 30 day follow-up visit

• Infusion rate evaluation (Expanded Safety Cohort)

  Every other week

• Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort

  Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up

Study Arms (1)

ABT-806 Arm

EXPERIMENTAL

Drug: ABT-806

Interventions

ABT-806 DRUG

ABT-806 will be administered by intravenous infusion.

ABT-806 Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (3)

Site Reference ID/Investigator# 54056

Baltimore, Maryland, 21231, United States

Location

Site Reference ID/Investigator# 41931

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator# 43422

Tacoma, Washington, 98405, United States

Location

Related 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 Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2.

  PMID: 25761639 RESULT

MeSH Terms

Interventions

depatuxizumab

Study Officials

• Kyle D. Holen, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 21, 2017

Record last verified: 2013-01

Locations

US (3)