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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001645-84 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A4 (ABBV-085) | Experimental | ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson |
|
| Arm A3 (ABBV-085) | Experimental | ABBV-085 will be administered at every cycle (28-day cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-085 | Drug | Administered as an intravenous infusion in 28-day dosing cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Terminal elimination half life of ABBV-085. | UP to 24 months | |
| Maximum observed plasma concentration (Cmax) of ABBV-085. | Up to 24 months | |
| Number of participants with Adverse Events | Collect all adverse events at each visit. | Up to 24 months |
| Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. | AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration. | Up 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR). | Up to 24 months |
| Progression free survival (PFS) |
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Inclusion Criteria:
Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
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).
All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
Participant has adequate bone marrow, renal, hepatic and cardiac function.
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona /ID# 148582 | Phoenix | Arizona | 85054 | United States | ||
| Scottsdale Healthcare /ID# 151349 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35260879 | Derived | Ray 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. |
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PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.
| Up to 24 months |
| Duration of overall response (DOR) | DOR is defined as the time from the participant's initial CR or PR to the time of disease progression. | Up to 24 months |
| Scottsdale |
| Arizona |
| 85258-4566 |
| United States |
| University of California, Los Angeles /ID# 148586 | Los Angeles | California | 90095 | United States |
| Univ of Colorado Cancer Center /ID# 148581 | Aurora | Colorado | 80045 | United States |
| University of Chicago /ID# 148579 | Chicago | Illinois | 60637-1443 | United States |
| Dana-Farber Cancer Institute /ID# 143782 | Boston | Massachusetts | 02215 | United States |
| Washington University-School of Medicine /ID# 151348 | St Louis | Missouri | 63110 | United States |
| NYU Langone Medical Center /ID# 150786 | New York | New York | 10016-6402 | United States |
| Duke Univ Med Ctr /ID# 148200 | Durham | North Carolina | 27710 | United States |
| Carolina BioOncology Institute /ID# 148583 | Huntersville | North Carolina | 28078 | United States |
| University of Pennsylvania /ID# 148576 | Philadelphia | Pennsylvania | 19104-5502 | United States |
| Greenville Hospital System /ID# 148652 | Greenville | South Carolina | 29605 | United States |
| Mary Crowley Cancer Research /ID# 148580 | Dallas | Texas | 75230 | United States |
| Univ TX, MD Anderson /ID# 147681 | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics /ID# 141715 | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists /ID# 148584 | Fairfax | Virginia | 22031 | United States |
| Gustave Roussy /ID# 150300 | Villejuif | Île-de-France Region | 94805 | France |
| Hospital Univ Ramon y Cajal /ID# 150799 | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz /ID# 148564 | Madrid | 28040 | Spain |
| Hosp Univ Madrid Sanchinarro /ID# 146039 | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D051677 | Histiocytoma, Malignant Fibrous |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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