Clinical trial NCT01255657: A Study of ABT-806 in Subjects With Advanced Solid Tumor Types
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety (Number of subjects with adverse events and/or dose-limiting toxicities)
timeFrame: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)
measure: Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort
timeFrame: Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit
measure: Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort
timeFrame: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up
Secondary outcomes:
measure: Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort
timeFrame: Week 1, 3, 7, 11, 15, 19, 23 and Final Visit
measure: QT assessment
timeFrame: Week 1, 7, 13, and 30 day follow-up visit
measure: Infusion rate evaluation (Expanded Safety Cohort)
timeFrame: Every other week
measure: Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort
timeFrame: Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 54056
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 41931
state: Massachusetts
city: Tacoma
country: United States
facility: Site Reference ID/Investigator# 43422
state: Washington
Study officials:
affiliation: AbbVie
name: Kyle D. Holen, MD
role: STUDY_DIRECTOR
References:
citation: 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.