A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.
18 Years and up
Accepting Healthy Volunteers?
1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
3. Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:
- Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).
4. All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
5. Participant has adequate bone marrow, renal, hepatic and cardiac function.
6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
1. Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
2. Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-085.
3. Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
4. Participant has ongoing hemolysis.
5. Major surgery within <=28 days prior to the first dose of ABBV-085.
6. Clinically significant uncontrolled condition(s).
7. Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.