for people ages 18-99 (full criteria)
at Orange, California and other locations
study started
estimated completion



This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 in subjects with advanced solid tumors.

Official Title

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors


Advanced Solid Tumors CancerCancerAdvanced Solid TumorNeoplasmNivolumabErlotinib HydrochlorideAntibodies, MonoclonalABBV-399ErlotinibMonotherapy ABBV-399 (21-day dosing cycles)Monotherapy ABBV-399 (28-day dosing cycles)


You can join if…

Open to people ages 18-99

  1. Subject must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  3. Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Subject has one archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
  5. Subject has adequate bone marrow, renal, and hepatic function.
  6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
  7. Subjects in the combination therapy arms must be eligible to receive erlotinib, or nivolumab per most current prescribing information, or at the discretion of the Investigator.

You CAN'T join if...

  1. Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or herbal therapy within 7 days prior to the first dose of ABBV-399.
  2. Subject has uncontrolled metastases to the central nervous system (CNS) based on head CT or MRI. Subjects with brain metastases may be eligible 2 weeks after definitive therapy to all known sites of CNS disease provided they are asymptomatic and either off or on a non-increasing dose (in last 2 weeks) of systemic steroids and not on anticonvulsants for seizure activity directly related to progressive CNS metastases.
  3. Subject has history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.
  4. Subject has unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  5. Subject has had major surgery within 21 days prior to the first dose of ABBV-399.
  6. Subject has a clinically significant uncontrolled condition(s) s described in the protocol.
  7. Subject has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  8. Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
  9. Subjects may not receive ABBV-399 in combination with erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities from the combination.


  • UC Irvine /ID# 165107accepting new patients
    OrangeCalifornia92868United States
  • City of Hope /ID# 153759accepting new patients
    DuarteCalifornia91010United States


accepting new patients
Start Date
Completion Date
Phase 1
Study Type
Last Updated