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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000478-45 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors | Experimental | Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927. |
|
| Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | Experimental | Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181. |
|
| Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC | Experimental | Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV. |
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| Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC | Experimental | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV. |
|
| Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-927 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Expansion: Objective Response Rate (ORR) | 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. | Up to approximately 2 years following the first dose of study drug |
| Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 | 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. | Up to approximately 6 months |
| Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181 | 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. | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Expansion Phase: Progression-free Survival (PFS) | PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first. | Up to approximately 2 years since the first dose of study drug |
| Dose-Expansion Phase: Duration of Response (DOR) |
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Inclusion Criteria:
Dose-Escalation:
Dose-Expansion:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group, PA /ID# 218863 | Springdale | Arkansas | 72762 | United States | ||
| St Jude Hospital dba St Joseph /ID# 211130 |
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| Experimental |
Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV. |
|
| Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC | Experimental | Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV. |
|
| Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC | Experimental | Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV. |
|
| ABBV-368 | Drug | Intravenous (IV) Infusion |
|
| ABBV-181 | Drug | Intravenous (IV) Infusion |
|
|
| Carboplatin | Drug | Intravenous (IV) Infusion |
|
| Nab-paclitaxel | Drug | Intravenous (IV) Infusion |
|
DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first. |
| Up to approximately 2 years since the first dose of study drug |
| Maximum Serum Concentration (Cmax) | Maximum Serum Concentration (Cmax) | Up to approximately 12 weeks after participant's initial dose of study drug |
| Time to Maximum Observed Serum Concentration (Tmax) | Time to Maximum Observed Serum Concentration (Tmax) | Up to approximately 12 weeks after participant's initial dose of study drug |
| Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ) | Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ). | Up to approximately 12 weeks after participant's initial dose of study drug |
| Terminal Phase Elimination Half-life (t1/2) | Terminal Phase Elimination Half-life (t1/2) | Up to approximately 4 weeks after participant's initial dose of study drug |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Yale University School of Medicine /ID# 210678 | New Haven | Connecticut | 06510 | United States |
| Moffitt Cancer Center /ID# 215037 | Tampa | Florida | 33612-9416 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 | Fort Wayne | Indiana | 46804 | United States |
| Washington University-School of Medicine /ID# 221399 | St Louis | Missouri | 63110 | United States |
| Duke Cancer Center /ID# 217641 | Durham | North Carolina | 27710-3000 | United States |
| Carolina BioOncology Institute /ID# 210664 | Huntersville | North Carolina | 28078 | United States |
| UPMC Hillman Cancer Ctr /ID# 222747 | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology-Nashville Centennial /ID# 221400 | Nashville | Tennessee | 37203-1632 | United States |
| Mary Crowley Cancer Research /ID# 210716 | Dallas | Texas | 75230 | United States |
| NEXT Oncology /ID# 210717 | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 210671 | Fairfax | Virginia | 22031 | United States |
| Duplicate_Icon Cancer Centre /ID# 224084 | South Brisbane | Queensland | 4101 | Australia |
| Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880 | Saint-Herblain | Loire-Atlantique | 44805 | France |
| Institut Curie /ID# 223475 | Paris | Paris | 75248 | France |
| Centre Leon Berard /ID# 217910 | Lyon | Rhone | 69373 | France |
| Centre Jean Perrin /ID# 217911 | Clermont-Ferrand | 63011 | France |
| AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869 | Paris | 75018 | France |
| The Chaim Sheba Medical Center /ID# 211699 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Hospital Universitario Vall d'Hebron /ID# 212804 | Barcelona | 08035 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 212806 | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro /ID# 212805 | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 221671 | Málaga | 29010 | Spain |
| National Taiwan University Hospital /ID# 210993 | Taipei City | Taipei | 100 | Taiwan |
| China Medical University Hospital /ID# 221090 | Taichung | 40447 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000719868 | budigalimab |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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