A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-927: Intravenous (IV) Infusion
ABBV-368: Intravenous (IV) Infusion
ABBV-181: Intravenous (IV) Infusion
Carboplatin: Intravenous (IV) Infusion
Nab-paclitaxel: Intravenous (IV) Infusion
Study summary
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Eligibility
Primary outcome measure(s)
- Dose Expansion: Objective Response Rate (ORR) — Up to approximately 2 years following the first dose of study drug
ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 — Up to approximately 6 months
The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data. - Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 — Up to approximately 6 months
The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Highlands Oncology Group, PA /ID# 218863 | Springdale | Arkansas | |
| St Jude Hospital dba St Joseph /ID# 211130 | Santa Rosa | California | |
| Yale University School of Medicine /ID# 210678 | New Haven | Connecticut | |
| Moffitt Cancer Center /ID# 215037 | Tampa | Florida | |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 | Fort Wayne | Indiana | |
| Washington University-School of Medicine /ID# 221399 | St Louis | Missouri | |
| Duplicate_Duke Cancer Center /ID# 217641 | Durham | North Carolina | |
| Carolina BioOncology Institute /ID# 210664 | Huntersville | North Carolina | |
| UPMC Hillman Cancer Ctr /ID# 222747 | Pittsburgh | Pennsylvania | |
| Tennessee Oncology-Nashville Centennial /ID# 221400 | Nashville | Tennessee | |
| Mary Crowley Cancer Research /ID# 210716 | Dallas | Texas | |
| NEXT Oncology /ID# 210717 | San Antonio | Texas | |
| Virginia Cancer Specialists - Fairfax /ID# 210671 | Fairfax | Virginia | |
| Duplicate_Icon Cancer Centre /ID# 224084 | South Brisbane | Queensland | |
| Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880 | Saint-Herblain | Loire-Atlantique | |
| Institut Curie /ID# 223475 | Paris | Paris | |
| Centre Leon Berard /ID# 217910 | Lyon | Rhone | |
| Centre Jean Perrin /ID# 217911 | Clermont-Ferrand | France | |
| AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869 | Paris | France | |
| The Chaim Sheba Medical Center /ID# 211699 | Ramat Gan | Tel Aviv | |
| Hospital Universitario Vall de Hebron /ID# 212804 | Barcelona | Spain | |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 212806 | Madrid | Spain | |
| Hospital Universitario HM Sanchinarro /ID# 212805 | Madrid | Spain | |
| Hospital Universitario Virgen de la Victoria /ID# 221671 | Málaga | Spain | |
| China Medical University Hospital /ID# 221090 | Taichung | Taiwan | |
| National Taiwan University Hospital /ID# 210993 | Taipei | Taiwan |
More AbbVie trials in Israel
Other trials for the same condition
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 NCT03893955 on ClinicalTrials.gov ↗ ← All trials in Israel