Advanced Solid TumorsPhase 1NCT02565758
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
A Phase 1 study testing ABBV-085 in people with Advanced Solid Tumors and Undifferentiated Pleomorphic Sarcoma, run by AbbVie at 20 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- ABBV-085
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 18 Sep 2015to 25 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
- 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.
- Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
- Participant has ongoing hemolysis.
- Major surgery within <=28 days prior to the first dose of ABBV-085.
- Clinically significant uncontrolled condition(s).
- Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States16 sites
Univ of Colorado Cancer Center /ID# 148581
Aurora, Colorado, 80045
Dana-Farber Cancer Institute /ID# 143782
Boston, Massachusetts, 02215
University of Chicago /ID# 148579
Chicago, Illinois, 60637-1443
Mary Crowley Cancer Research /ID# 148580
Dallas, Texas, 75230
Duke Univ Med Ctr /ID# 148200
Durham, North Carolina, 27710
Virginia Cancer Specialists /ID# 148584
Fairfax, Virginia, 22031
Greenville Hospital System /ID# 148652
Greenville, South Carolina, 29605
Univ TX, MD Anderson /ID# 147681
Houston, Texas, 77030
Carolina BioOncology Institute /ID# 148583
Huntersville, North Carolina, 28078
University of California, Los Angeles /ID# 148586
Los Angeles, California, 90095
NYU Langone Medical Center /ID# 150786
New York, New York, 10016-6402
University of Pennsylvania /ID# 148576
Philadelphia, Pennsylvania, 19104-5502
Mayo Clinic Arizona /ID# 148582
Phoenix, Arizona, 85054
South Texas Accelerated Research Therapeutics /ID# 141715
San Antonio, Texas, 78229
Scottsdale Healthcare /ID# 151349
Scottsdale, Arizona, 85258-4566
Washington University-School of Medicine /ID# 151348
St Louis, Missouri, 63110
Spain3 sites
Hospital Univ Ramon y Cajal /ID# 150799
Madrid, 28034
Fundacion Jimenez Diaz /ID# 148564
Madrid, 28040
Hosp Univ Madrid Sanchinarro /ID# 146039
Madrid, 28050
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Carcinoma of the Breast
- Being tested
- ABBV-085
- Keywords
- Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate
- Medical subject headings
- Histiocytoma, Malignant Fibrous, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-085Drug
Administered as an intravenous infusion in 28-day dosing cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm A4 (ABBV-085) | Experimental | ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson Receives: Drug: ABBV-085 |
| Arm A3 (ABBV-085) | Experimental | ABBV-085 will be administered at every cycle (28-day cycles). Receives: Drug: ABBV-085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Terminal elimination half life of ABBV-085.
Measured: UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Measured: Up to 24 months
Number of participants with Adverse Events
Collect all adverse events at each visit.
Measured: 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.
Measured: Up 24 months
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).
Measured: Up to 24 months
Progression free survival (PFS)
PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start18 Sep 2015
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565758
- Sponsor's protocol ID
- M15-394
- Other IDs
- 2015-001645-84, 2015
- Status last verified
- Apr 2019
- First submitted
- 30 Sep 2015
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35260879
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02565758
- Acronym / sponsor ID
- M15-394
- Conditions
- Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Carcinoma of the Breast
- Keywords
- Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A4 (ABBV-085) | Experimental | Drug: ABBV-085ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson |
| Arm A3 (ABBV-085) | Experimental | Drug: ABBV-085ABBV-085 will be administered at every cycle (28-day cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
- 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.
- Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
- Participant has ongoing hemolysis.
- Major surgery within <=28 days prior to the first dose of ABBV-085.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-085Administered as an intravenous infusion in 28-day dosing cycles. | Drug | Arm A3 (ABBV-085), Arm A4 (ABBV-085) |
Primary outcome
Terminal elimination half life of ABBV-085.
Time frame: UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Time frame: Up to 24 months
Number of participants with Adverse Events
Time frame: Up to 24 months
Collect all adverse events at each visit.
Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
Time frame: Up 24 months
AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.
3 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 months
Progression free survival (PFS)
Time frame: Up to 24 months
Duration of overall response (DOR)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 35260879Ray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-085 in people with Advanced Solid Tumors and Undifferentiated Pleomorphic Sarcoma, run by AbbVie at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Terminal elimination half life of ABBV-085. (time frame: UP to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.