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

About this Study

This study is designed to evaluate the safety and pharmacokinetics and
determine the recommended Phase 2 dose (RPTD) of ABBV-399 in
subjects with advanced solid tumors.

Sponsor Protocol ID:ABBV-399
IRB Number:2020-0160
Closed for Enrollment
Phase 1
July 17, 2020
Eligibility Criteria
Both Male and Female

Inclusion Criteria
 Subject must be ≥ 18 years of age.
 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

 Subject has adequate bone marrow, renal, and hepatic

 Women of childbearing potential must have a negative serum
pregnancy test within 14 days prior to initiation of treatment.

Exclusion Criteria
 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

 Subject has history of interstitial lung disease (ILD) or
pneumonitis that required treatment with systemic steroids,
or any evidence of active ILD or pneumonitis.

 Subject has unresolved clinically significant adverse events >=
Grade 2 from prior anticancer therapy, except for alopecia or

 Subject has had major surgery within 21 days prior to the first
dose of ABBV-399.

 Subject has a clinically significant condition(s) described in the

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-815-4540
Email: jbarnes@umc.edu
Principal Investigator:Tang, Shou-Ching, M.D.Ph.D., M.D., Ph.D.
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