Clinical trial · Interventional
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
NCT02565758CI-TRIAL-00037954completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Carcinoma of the Breast | Breast Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Undifferentiated Pleomorphic Sarcoma | Undifferentiated Pleomorphic Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-085 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A4 (ABBV-085)
- description
- ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
- interventionNames
- Drug: ABBV-085
- type
- EXPERIMENTAL
- label
- Arm A3 (ABBV-085)
- description
- ABBV-085 will be administered at every cycle (28-day cycles).
- interventionNames
- Drug: ABBV-085
Primary outcomes (4)
- measure
- Terminal elimination half life of ABBV-085.
- timeFrame
- UP to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRay U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734. PMID 35260879