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 : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: Venetoclax Drug: Rovalpituzumab Tesirine Drug: ABBV-181||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||221 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 :||September 25, 2021|
|Estimated Study Completion Date :||December 27, 2021|
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 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. 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 or venetoclax.
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
Experimental: ABBV-181 plus Venetoclax
Venetoclax will be taken once daily beginning 7 days prior to cycle 1 and continuing daily for a 28 day cycle and ABBV-181 will be administered every 4 weeks.
Tablet taken orally
- Recommended Phase 2 Dose (RPTD) and schedule for ABBV-181 and venetoclax combination. [ Time Frame: Up to 6 months ]The safety and tolerability of ABBV-181 in combination with venetoclax will be assessed in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) to determine the RPTD for the combination.
- 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.
- 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.
- Time to Cmax (Tmax) [ 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) ]
- Area under the serum concentration time curve (AUC) [ Time Frame: Up to 12 weeks after participant's first dose ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 12 weeks after participant's first dose ]
- Terminal half-life (t1/2) [ Time Frame: Up to 4 weeks after participant's first dose ]
- 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.
- Objective response rate (ORR) [ Time Frame: First dose of study drug through at least 30 days after last dose of study drug. ]ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
- Clinical benefit rate (CBR, defined as CR, PR or SD) [ Time Frame: First dose of study drug through at least 30 days after last dose of study drug. ]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 last dose of study drug. ]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 last dose of study drug. ]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.
- 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 last dose of study drug. ]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.
- Anti-tumor effect of ABBV-181 in combination with venetoclax. [ Time Frame: First dose of study drug through at least 30 days after last dose of study drug. ]The overall safety and tolerability of ABBV-181 and venetroclax when given in combination will be evaluated.
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 /Id# 157374||Recruiting|
|La Jolla, California, United States, 92093|
|United States, Illinois|
|University of Chicago /ID# 157375||Recruiting|
|Chicago, Illinois, United States, 60637-1443|
|United States, North Carolina|
|Carolina BioOncology Institute /ID# 157376||Recruiting|
|Huntersville, North Carolina, United States, 28078|
|United States, Texas|
|South Texas Accelerated Research Therapeutics /ID# 157378||Recruiting|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Virginia Cancer Specialists /ID# 157377||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Australia, New South Wales|
|Blacktown Hospital /ID# 167386||Recruiting|
|Blacktown, New South Wales, Australia, 2148|
|St. Vincents Hosp Melbourne /ID# 167552||Recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Australia, Western Australia|
|Linear Clinical Research /ID# 170797||Recruiting|
|Perth, Western Australia, Australia, 6000|
|LKH-Univ. Klinikum Graz /ID# 168752||Completed|
|Graz, Austria, 8036|
|Medizinische Universitaet Wien /ID# 169781||Not yet recruiting|
|Vienna, Austria, 1090|
|UZ Gent /ID# 170881||Recruiting|
|Gent, Oost-Vlaanderen, Belgium, 9000|
|UZ Antwerpen /ID# 170702||Recruiting|
|Edegem, Belgium, 2650|
|Cross Cancer Institute /ID# 167603||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Docrates Cancer Center /ID# 166838||Recruiting|
|Helsinki, Finland, 00180|
|Tampere University Hospital /ID# 166839||Recruiting|
|Tampere, Finland, 33521|
|Institut Bergonie /ID# 162662||Recruiting|
|Bordeaux, Gironde, France, 33000|
|Institut Regional du Cancer /ID# 163999||Recruiting|
|Montpellier CEDEX 5, Herault, France, 34298|
|Centre Leon Berard /ID# 162660||Recruiting|
|Lyon CEDEX 08, Rhone, France, 69373|
|Institut Gustave Roussy /ID# 162753||Recruiting|
|Villejuif, Val-de-Marne, France, 94800|
|National Cancer Ctr Hosp East /ID# 166433||Recruiting|
|Kashiwa-shi, Chiba, Japan, 277-8577|
|National Hospital Organization Kyushu Cancer Center /ID# 206229||Recruiting|
|Fukuoka-shi, Fukuoka, Japan, 811-1395|
|National Cancer Center Hospital /ID# 166279||Recruiting|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Hospital Universitario Fundacion Jimenez Diaz /ID# 163862||Recruiting|
|Madrid, Spain, 28040|
|Hosp Univ Madrid Sanchinarro /ID# 163861||Recruiting|
|Madrid, Spain, 28050|
|Hosp Clin Univ de Valencia /ID# 163925||Recruiting|
|Valencia, Spain, 46010|
|National Taiwan Univ Hosp /ID# 163997||Recruiting|
|Taipei City, Taipei, Taiwan, 10002|
|Taipei Medical University Hosp /ID# 163998||Recruiting|
|Taipei City, Taiwan, 11031|
|Study Director:||AbbVie Inc.||AbbVie|