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CompletedNCT01741727Updated Nov 20, 2017

A Study of ABT-414 in Subjects With Solid Tumors

A Phase 1 interventional study of ABT-414 in Squamous Cell Tumors, sponsored by AbbVie (prior sponsor, Abbott). Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

A study of ABT-414 in subjects with solid tumors.

02

Conditions studied

  • Squamous Cell Tumors
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In context

Neoplasms, Squamous Cell

134 studies on the registry are indexed under Neoplasms, Squamous Cell; 14 are open to participants now.

This study's enrollment of 57 is above the median of 43 across 113 interventional studies indexed under Neoplasms, Squamous Cell.

Browse Neoplasms, Squamous Cell studies →

Lead sponsor

AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
  2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  3. Subjects have available tumor tissue
  4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3; Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine \</= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \</= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of \</= 5.0 x the upper limit of normal.
  5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
  6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort

Exclusion criteria

Exclusion Criteria:

  1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
  2. The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
  3. The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
  5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    ABT-414

    Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)

    Drug: ABT-414

Interventions

  • DrugABT-414

    ABT-414 will be administered by intravenous infusion.

06

What researchers measure

Primary outcomes

  1. Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)

    Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.

    Time frame: Every 1-3 weeks for an average of 20 weeks

  2. Phase 1 - Pharmacokinetic profile

    Cmax, Cmin, and half-life

    Time frame: Multiple timepoints Week 1 and Week 7

  3. Phase 2 - Efficacy

    Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)

    Time frame: Every 6-9 weeks for an average of 20 weeks

Secondary outcomes

  1. Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)

    Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic)

    Time frame: Followed on average every 3 weeks for approximately 20 weeks

  2. Phase 2- Pharmacokinetic profile

    Cmax, Cmin, and half-life

    Time frame: Multiple timepoints Week 1

  3. Phase 1&2 - QT assessment

    Triplicate electrocardiograms

    Time frame: Week 1

07

Study locations

6 sites
  • Site Reference ID/Investigator# 90333
    Scottsdale, Arizona 85258, United States
  • Site Reference ID/Investigator# 83156
    Chicago, Illinois 60637, United States
  • Site Reference ID/Investigator# 117516
    Boston, Massachusetts 02215, United States
  • Site Reference ID/Investigator# 83154
    Boston, Massachusetts 02215, United States
  • Site Reference ID/Investigator# 83155
    San Antonio, Texas 78229, United States
  • Site Reference ID/Investigator# 89035
    Ottawa, K1H 8L6, Canada
08

References and documents

Publications

  • Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27. PubMed 28349167 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01741727
Lead sponsor
AbbVie (prior sponsor, Abbott)
Responsible party
Sponsor
First posted
Dec 5, 2012
Start date
Oct 2012
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Nov 20, 2017

Study contacts

Christopher Ocampo, MD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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