ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | September 18, 2015 |
End Date: | March 25, 2019 |
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.
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.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
We found this trial at
17
sites
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9801 Kincey Avenue
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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4383 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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