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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02988960
Other study ID # M15-862
Secondary ID 2016-002219-16
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 22, 2017
Est. completion date March 30, 2025

Study information

Verified date June 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 information / eligibility

Status Active, not recruiting
Enrollment 163
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABBV-927
Intravenous
ABBV-927
Intratumoral
ABBV-181
Intravenous

Locations

Country Name City State
Australia Peninsula Oncology Centre /ID# 164372 Frankston Victoria
Australia Austin Health /ID# 171189 Heidelberg Victoria
Canada Princess Margaret Cancer Centre /ID# 200819 Toronto Ontario
France Institut Bergonie /ID# 162665 Bordeaux Gironde
France Centre Leon Berard /ID# 162663 Lyon CEDEX 08 Rhone
France Duplicate_Institut Regional du Cancer /ID# 163609 Montpellier CEDEX 5 Herault
France Institut Gustave Roussy /ID# 162666 Villejuif Cedex Val-de-Marne
Japan National Cancer Center Hospital /ID# 217758 Chuo-ku Tokyo
Japan National Cancer Center Hospital East /ID# 216870 Kashiwa-shi Chiba
Korea, Republic of Seoul National University Hospital /ID# 166291 Seoul
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 166292 Seoul Seoul Teugbyeolsi
Spain Hospital Universitario Fundacion Jimenez Diaz /ID# 200128 Madrid
Spain Hospital Universitario HM Sanchinarro /ID# 200127 Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129 Majadahonda Madrid
Spain Hospital Universitario y Politecnico La Fe /ID# 200975 Valencia
United States Massachusetts General Hospital /ID# 155267 Boston Massachusetts
United States The University of Chicago Medical Center /ID# 155264 Chicago Illinois
United States Virginia Cancer Specialists - Fairfax /ID# 155266 Fairfax Virginia
United States University of Texas MD Anderson Cancer Center /ID# 155263 Houston Texas
United States Carolina BioOncology Institute /ID# 155265 Huntersville North Carolina
United States The Angeles Clinic and Researc /ID# 156324 Los Angeles California
United States Tennessee Oncology-Nashville Centennial /ID# 158654 Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin. Up to 8 weeks
Primary Time to Cmax (Tmax) of ABBV-927 Time to Cmax (Tmax) of ABBV-927. Up to 12 weeks after participant's first dose
Primary Maximum observed serum concentration (Cmax) of ABBV-927 Maximum observed serum concentration (Cmax) of ABBV-927. Up to 12 weeks after participant's first dose
Primary Terminal-Phase Elimination Rate Constant (ß) of ABBV-927 Terminal-phase elimination rate constant (ß)of ABBV-927. Up to 12 weeks after participant's first dose
Primary Terminal half-life (t1/2) of ABBV-927 Terminal half-life (t1/2) of ABBV-927. Up to 4 weeks after participant's first dose
Primary Area under the serum concentration-time curve (AUCt) of ABBV-927 Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927. Up to 12 weeks after participant's first dose
Primary Time to Cmax (Tmax) of ABBV-181 Time to Cmax (Tmax) of ABBV-181. Up to 12 weeks after participant's first dose
Primary Maximum observed serum concentration (Cmax) of ABBV-181 Maximum observed serum concentration (Cmax) of ABBV-181. Up to 12 weeks after participant's first dose
Primary Terminal-Phase Elimination Rate Constant (ß) of ABBV-181 Terminal-phase elimination rate constant (ß)of ABBV-181. Up to 12 weeks after participant's first dose
Primary Terminal half-life (t1/2) of ABBV-181 Terminal half-life (t1/2) of ABBV-181. Up to 4 weeks after participant's first dose
Primary Area under the serum concentration-time curve (AUCt) of ABBV-181 Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181. Up to 12 weeks after participant's first dose
Primary Number of Participants with Adverse Events An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Up to 30 days after and up to 24-month of treatment period
Secondary Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment) CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment. Up to 30 days after and up to 24-month of treatment period
Secondary Duration of objective response (DOR) DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first. Up to 30 days after and up to 24-month of treatment period
Secondary Objective response rate (ORR) ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment. Up to 30 days after and up to 24-month of treatment period
Secondary Progression-free survival (PFS) PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first. Up to 30 days after and up to 24-month of treatment period
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