A Study of ABBV-181 in Participants With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03000257|
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: Rovalpituzumab Tesirine Drug: ABBV-181||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody, as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||December 14, 2016|
|Estimated Primary Completion Date :||November 14, 2018|
|Estimated Study Completion Date :||December 18, 2019|
In the Monotherapy Escalation portion of the study, ABBV-181 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Based on available safety, pharmacokinetic, and pharmacodynamic data from the dose-escalation part of the study, participants will be enrolled in tumor-specific dose-expansion cohorts to further evaluate ABBV-181 at a dose level which is at or below the Maximum tolerated dose (MTD). In the Monotherapy Expansion portion of the study, ABBV-181 will be administered in 28-day dosing cycles at either 1 dose per cycle or 2 doses per cycle.
In the Combination portion of the study, ABBV-181 will be administered in combination with Rovalpituzumab Tesirine in 21-day dosing cycles. Based on available safety, PK and PD data from the single agent dose-escalation part of the study, a dose for ABBV-181 will be selected to evaluate in combination with Rovalpituzumab Tesirine.
Drug: Rovalpituzumab Tesirine
Intravenous infusionDrug: ABBV-181
Experimental: ABBV-181 plus Rovalpituzumab Tesirine
Rovalpituzumab Tesirine will be given once every six weeks times two doses and ABBV-181 will be administered every 3 weeks.
Drug: Rovalpituzumab Tesirine
Intravenous infusionDrug: ABBV-181
- Recommended Phase 2 Dose (RPTD) and schedule for ABBV-181 and Rovalpituzumab Tesirine combination [ Time Frame: Up to 6 months ]The safety and tolerability of a single dose of ABBV-181 in combination with Rovalpituzumab Tesirine will be assessed in patients with advanced small cell lung cancer (SCLC) to determine the RPTD and schedule for the combination.
- Terminal half-life (t1/2) [ Time Frame: Up to 4 weeks after participant's first dose ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 12 weeks after participant's first dose ]
- Area under the serum concentration time curve (AUC) [ Time Frame: Up to 12 weeks after participant's first dose ]
- Number of participants with adverse events [ Time Frame: From first dose of study drug until 90 days following last dose of study drug (up to 24 months) ]
- Time to Cmax (Tmax) [ Time Frame: Up to 12 weeks after participant's first dose ]
- Recommended Phase 2 Dose (RPTD) for ABBV-181 [ Time Frame: Up to 6 months ]If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-181 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and other available data.
- Maximum tolerated dose (MTD) of ABBV-181 [ Time Frame: Up to 6 months ]MTD will be defined at the highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
- Objective response rate (ORR) [ Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period ]ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
- Preliminary response and activity of ABBV-181 and Rovalpituzumab Tesirine when given in combination [ Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period ]The overall safety and tolerability of ABBV-181 and Rovalpituzumab Tesirine when given in combination will be evaluated. The immunogenicity of the combination will also be evaluated.
- Clinical benefit rate (CBR, defined as CR, PR or SD) [ Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period ]CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease.
- Progression-free survival (PFS) [ Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period ]PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death, whichever occurs first.
- Duration of objective response (DOR) [ Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period ]DOR for a participant is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000257
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, California|
|UCSD||Not yet recruiting|
|San Diego, California, United States, 92122|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637-1443|
|United States, North Carolina|
|Carolina BioOncology Institute||Recruiting|
|Huntersville, North Carolina, United States, 28078|
|United States, Texas|
|South TX Accelerated Research||Recruiting|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Virginia Cancer Specialists, P||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Australia, New South Wales|
|Blacktown, New South Wales, Australia, 2148|
|St. Vincents Hosp Melbourne||Not yet recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Australia, Western Australia|
|Linear Clinical Research||Not yet recruiting|
|Perth, Western Australia, Australia, 6000|
|Cross Cancer Institute||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2X8|
|Institut Gustave Roussy||Recruiting|
|Villejuif, Val-de-Marne, France, 94800|
|Bordeaux, France, 33000|
|Centre Leon Berard||Recruiting|
|Lyon CEDEX 08, France, 69373|
|Institut Regional du Cancer||Recruiting|
|Montpellier, France, 34298|
|AOU di Bologna Policlinico||Not yet recruiting|
|Bologna, Italy, 40138|
|IRCCS IC Humanitas||Not yet recruiting|
|Milan, Italy, 20089|
|National Cancer Center Hosp||Not yet recruiting|
|中央区, Tokyo, Japan, 〒104-0045|
|National Cancer Ctr Hosp East||Not yet recruiting|
|Kashiwa, Japan, 277-8577|
|Hospital Universitario Fundaci||Recruiting|
|Madrid, Spain, 28040|
|Hosp Univ Madrid Sanchinarro||Not yet recruiting|
|Madrid, Spain, 28050|
|Hosp Clin Univ de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Study Director:||AbbVie Inc.||AbbVie|