A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
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. Enrollment is closed for Arms A and D.
18 Years to 99 Years
Accepting Healthy Volunteers?
- 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.
- 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.
- Subject has fresh and/or archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
- Subject has adequate bone marrow, renal, and hepatic function.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
- Subjects in the combination therapy arms A and D must be eligible to receive erlotinib, or nivolumab per most current prescribing information, or at the discretion of the Investigator.
- Subjects in the combination therapy Arm E must satisfy following criteria.
- Subject must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q.
- Subject must have discontinued osimertinib due to disease progression.
- Subject must have available post-progression tumor tissue for central c-Met immunohistochemistry (IHC) testing.
- 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.
- 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.
- 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 anemia.
- 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 protocol.
- Subject has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
- Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
- Subjects may not receive ABBV-399 in combination with osimertinib, 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.
- Solid Tumors