A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-927: Intravenous
ABBV-927: Intratumoral
ABBV-181: Intravenous
Study 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.
Eligibility
Primary outcome measure(s)
- Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 — Up to 8 weeks
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. - Time to Cmax (Tmax) of ABBV-927 — Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-927. - Maximum observed serum concentration (Cmax) of ABBV-927 — Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-927. - Terminal-Phase Elimination Rate Constant (β) of ABBV-927 — Up to 12 weeks after participant's first dose
Terminal-phase elimination rate constant (β)of ABBV-927. - Terminal half-life (t1/2) of ABBV-927 — Up to 4 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-927. - Area under the serum concentration-time curve (AUCt) of ABBV-927 — Up to 12 weeks after participant's first dose
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927. - Time to Cmax (Tmax) of ABBV-181 — Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181. - Maximum observed serum concentration (Cmax) of ABBV-181 — Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-181. - Terminal-Phase Elimination Rate Constant (β) of ABBV-181 — Up to 12 weeks after participant's first dose
Terminal-phase elimination rate constant (β)of ABBV-181. - Terminal half-life (t1/2) of ABBV-181 — Up to 4 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-181. - Area under the serum concentration-time curve (AUCt) of ABBV-181 — Up to 12 weeks after participant's first dose
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181. - Number of Participants with Adverse Events — Up to 30 days after and up to 24-month of treatment period
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.
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| The Angeles Clinic and Researc /ID# 156324 | Los Angeles | California | |
| The University of Chicago Medical Center /ID# 155264 | Chicago | Illinois | |
| Massachusetts General Hospital /ID# 155267 | Boston | Massachusetts | |
| Carolina BioOncology Institute /ID# 155265 | Huntersville | North Carolina | |
| Tennessee Oncology-Nashville Centennial /ID# 158654 | Nashville | Tennessee | |
| University of Texas MD Anderson Cancer Center /ID# 155263 | Houston | Texas | |
| Virginia Cancer Specialists - Fairfax /ID# 155266 | Fairfax | Virginia | |
| Peninsula Oncology Centre /ID# 164372 | Frankston | Victoria | |
| Austin Health /ID# 171189 | Heidelberg | Victoria | |
| University Health Network_Princess Margaret Cancer Centre /ID# 200819 | Toronto | Ontario | |
| Institut Bergonie /ID# 162665 | Bordeaux | Gironde | |
| Duplicate_Institut Regional du Cancer /ID# 163609 | Montpellier | Herault | |
| Centre Leon Berard /ID# 162663 | Lyon | Rhone | |
| Institut Gustave Roussy /ID# 162666 | Villejuif | Val-de-Marne | |
| National Cancer Center Hospital East /ID# 216870 | Kashiwa-shi | Chiba | |
| National Cancer Center Hospital /ID# 217758 | Chuo-ku | Tokyo | |
| Seoul National University Hospital /ID# 166291 | Seoul | Seoul Teugbyeolsi | |
| Yonsei University Health System Severance Hospital /ID# 166292 | Seoul | South Korea | |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 200129 | Majadahonda | Madrid | |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 200128 | Madrid | Spain | |
| Hospital Universitario HM Sanchinarro /ID# 200127 | Madrid | Spain | |
| Hospital Universitario y Politecnico La Fe /ID# 200975 | Valencia | Spain |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02988960 on ClinicalTrials.gov ↗ ← All trials in France