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Clinical Trial Finder

Search Results

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors

Study Purpose

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • - Participants have adequate bone marrow, kidney and liver function.
  • - Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.
  • - Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
  • - Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.
  • - Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
  • - Participants in all combination therapy arms must have recurrent or metastatic HNSCC or NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy.
In addition, participants must have received only one prior immunotherapy.
  • - The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.

Exclusion Criteria:

  • - Participant must not have an active or prior documented autoimmune disease in the last 2 years.
  • - Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
  • - Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis.
  • - Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.
  • - Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.
  • - Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
  • - Participant must not have a known uncontrolled malignancy of the central nervous system.
  • - Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.
  • - Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
  • - Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
  • - Participant is judged by the investigator to have evidence of hemolysis.
  • - For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02988960
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Australia, Canada, France, Japan, South Korea, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumors Cancer
Arms & Interventions

Arms

Experimental: Escalating Arm 1: ABBV-927

Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Experimental: Escalating Arm 2: ABBV-927

Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.

Experimental: Escalating Arm 3: ABBV-927+ABBV-181

Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Escalating Arm 4: ABBV-927+ABBV-181

Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Escalating Arm 5 (Japan): ABBV-927

Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Experimental: Escalating Arm 6 (Japan): ABBV-927+ABBV-181

Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Expansion Arm A: ABBV-927

Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.

Experimental: Expansion Arm B: ABBV-927+ABBV-181

Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Expansion Arm C: ABBV-927+ABBV-181

Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.

Interventions

Drug: - ABBV-927

Intravenous

Drug: - ABBV-927

Intratumoral

Drug: - ABBV-181

Intravenous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles 5368361, California 5332921

Status

Address

The Angeles Clinic and Researc /ID# 156324

Los Angeles 5368361, California 5332921, 90025

Chicago 4887398, Illinois 4896861

Status

Address

The University of Chicago Medical Center /ID# 155264

Chicago 4887398, Illinois 4896861, 60637-1443

Boston 4930956, Massachusetts 6254926

Status

Address

Massachusetts General Hospital /ID# 155267

Boston 4930956, Massachusetts 6254926, 02114

Huntersville 4472370, North Carolina 4482348

Status

Address

Carolina BioOncology Institute /ID# 155265

Huntersville 4472370, North Carolina 4482348, 28078

Nashville 4644585, Tennessee 4662168

Status

Address

Tennessee Oncology-Nashville Centennial /ID# 158654

Nashville 4644585, Tennessee 4662168, 37203-1632

Houston 4699066, Texas 4736286

Status

Address

University of Texas MD Anderson Cancer Center /ID# 155263

Houston 4699066, Texas 4736286, 77030

Fairfax 4758023, Virginia 6254928

Status

Address

Virginia Cancer Specialists - Fairfax /ID# 155266

Fairfax 4758023, Virginia 6254928, 22031

International Sites

Peninsula Oncology Centre /ID# 164372, Frankston 2166144, Victoria 2145234, Australia

Status

Address

Peninsula Oncology Centre /ID# 164372

Frankston 2166144, Victoria 2145234, 3199

Austin Health /ID# 171189, Heidelberg 2163654, Victoria 2145234, Australia

Status

Address

Austin Health /ID# 171189

Heidelberg 2163654, Victoria 2145234, 3084

Toronto 6167865, Ontario 6093943, Canada

Status

Address

University Health Network_Princess Margaret Cancer Centre /ID# 200819

Toronto 6167865, Ontario 6093943, M5G 2M9

Institut Bergonie /ID# 162665, Bordeaux 3031582, Gironde, France

Status

Address

Institut Bergonie /ID# 162665

Bordeaux 3031582, Gironde, 33000

Montpellier 2992166, Herault, France

Status

Address

Duplicate_Institut Regional du Cancer /ID# 163609

Montpellier 2992166, Herault, 34298

Centre Leon Berard /ID# 162663, Lyon 2996944, Rhone, France

Status

Address

Centre Leon Berard /ID# 162663

Lyon 2996944, Rhone, 69373

Institut Gustave Roussy /ID# 162666, Villejuif 2968705, Val-de-Marne, France

Status

Address

Institut Gustave Roussy /ID# 162666

Villejuif 2968705, Val-de-Marne, 94805

Kashiwa-shi, Chiba 2113014, Japan

Status

Address

National Cancer Center Hospital East /ID# 216870

Kashiwa-shi, Chiba 2113014, 277-8577

Chuo-ku, Tokyo 1850144, Japan

Status

Address

National Cancer Center Hospital /ID# 217758

Chuo-ku, Tokyo 1850144, 104-0045

Seoul 1835848, Seoul Teugbyeolsi, South Korea

Status

Address

Seoul National University Hospital /ID# 166291

Seoul 1835848, Seoul Teugbyeolsi, 03080

Seoul 1835848, South Korea

Status

Address

Yonsei University Health System Severance Hospital /ID# 166292

Seoul 1835848, , 03722

Majadahonda 3117667, Madrid 3117732, Spain

Status

Address

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129

Majadahonda 3117667, Madrid 3117732, 28222

Madrid 3117735, Spain

Status

Address

Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

Madrid 3117735, , 28040

Madrid 3117735, Spain

Status

Address

Hospital Universitario HM Sanchinarro /ID# 200127

Madrid 3117735, , 28050

Valencia 2509954, Spain

Status

Address

Hospital Universitario y Politecnico La Fe /ID# 200975

Valencia 2509954, , 46026

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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