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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002495-12 | EudraCT Number |
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An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel.
In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b).
In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).
The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalation 1a: ABBV-155 | Experimental | Participants will be administered ABBV-155 (various doses). |
|
| Escalation 1b: ABBV-155 + paclitaxel or docetaxel | Experimental | Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel . |
|
| Expansion 2a: ABBV-155 in SCLC | Experimental | Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose). |
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| Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer | Experimental | Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel. |
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| Expansion 2b: ABBV-155 + docetaxel in NSCLC | Experimental | Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-155 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD and/or RPTD of ABBV-155 | The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1). | Up to approximately 21 days after initial dose of study drug |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to approximately 2 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to approximately 12 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Has a histologic or cytologic diagnosis of a malignant solid tumor.
Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung cancer (SCLC) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC or HR-positive/HER2-negative breast cancer.
Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Failure of at least 1 prior systemic chemotherapy including all available standard therapies for participants in the dose-escalation phase (Parts 1a and 1b) including the safety lead-in phase (Japan only).
All participants with breast cancer for subjects in the dose-expansion phase (Part 2b only) must have the following:
All participants with non-small cell lung cancer (NSCLC) for participants in the dose-expansion phase (Part 2b only) must have R/R NSCLC after at least 1 line of therapy. Participants with activating mutations in EGFR, ALK/ROS1, BRAF genes, or with positive expression of PD-L1 must have been treated with the appropriate targeted therapies.
All participants with SCLC in the dose-expansion phase (Part 2a only) must have R/R SCLC from at least 1 line of therapy which includes a platinum-based therapy with or without an anti-PD-1/PD-L1 therapy.
All participants with either breast cancer or NSCLC must have the following if exposed to prior taxane-based therapy:
Available tumor tissue suitable for immunohistochemistry testing.
Adequate kidney, liver, and hematologic laboratory values as described in the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 214024 | Birmingham | Alabama | 35233 | United States | ||
| Highlands Oncology Group, PA /ID# 201568 |
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|
| Paclitaxel | Drug | Intravenous (IV) Infusion |
|
| Docetaxel | Drug | Intravenous (IV) Infusion |
|
DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first. |
| Up to approximately 12 months |
| Rate of Complete Response (CR) | CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1 | Up to approximately 2 to 6 months |
| Progression-Free Survival (PFS) | PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first. | Up to approximately 12 months |
| Overall Survival (OS) | OS is defined as the number of days from the date of first study drug to the date of death due to any cause. | Up to approximately 12 months after last dose of study drug |
| Cmax of ABBV-155 | Maximum plasma concentration (Cmax). | Up to approximately 48 days |
| Tmax of ABBV-155 | Time to maximum plasma concentration (Tmax). | Up to approximately 48 days |
| Terminal Phase Elimination Rate constant of ABBV-155 | Terminal phase elimination rate constant of ABBV-155 | Up to approximately 48 days |
| AUCt of ABBV-155 | Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt). | Up to approximately 48 days |
| AUCinf of ABBV-155 | AUC from time 0 to infinite time (AUCinf). | Up to approximately 48 days |
| QTcF Change from Baseline | QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy. | Up to approximately 8 days |
| t1/2 of ABBV-155 | Terminal elimination half-life (t1/2). | Up to approximately 48 days |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105 | Orange | California | 92868-3201 | United States |
| Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267 | West Hollywood | California | 90048 | United States |
| Univ of Colorado Cancer Center /ID# 208365 | Aurora | Colorado | 80045 | United States |
| Yale University, Yale Cancer Center /ID# 201542 | New Haven | Connecticut | 06510-3206 | United States |
| AdventHealth Orlando /ID# 227242 | Orlando | Florida | 32803 | United States |
| Northwestern University Feinberg School of Medicine /ID# 201563 | Chicago | Illinois | 60611-2927 | United States |
| Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095 | Baltimore | Maryland | 21224 | United States |
| Johns Hopkins Hospital /ID# 201320 | Baltimore | Maryland | 21287 | United States |
| Dana-Farber Cancer Institute /ID# 201564 | Boston | Massachusetts | 02215 | United States |
| Duplicate_Henry Ford Hospital /ID# 226852 | Detroit | Michigan | 48202 | United States |
| Northwell Health - Marcus Ave /ID# 204376 | New Hyde Park | New York | 11042-2060 | United States |
| Carolina BioOncology Institute /ID# 201577 | Huntersville | North Carolina | 28078 | United States |
| Univ Hosp Cleveland /ID# 201567 | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma, Stephenson Cancer Center /ID# 206820 | Oklahoma City | Oklahoma | 73104-5418 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 204256 | Providence | Rhode Island | 02903-4923 | United States |
| Vanderbilt Ingram Cancer Center /ID# 201575 | Nashville | Tennessee | 37232-0021 | United States |
| Mary Crowley Cancer Research /ID# 214168 | Dallas | Texas | 75230 | United States |
| MD Anderson Cancer Center /ID# 201558 | Houston | Texas | 77030 | United States |
| NEXT Oncology /ID# 204893 | San Antonio | Texas | 78229 | United States |
| Peter MacCallum Cancer Center /ID# 241676 | Melbourne | New South Wales | 3000 | Australia |
| Duplicate_Cross Cancer Institute /ID# 213838 | Edmonton | Alberta | T6G 1Z2 | Canada |
| University Health Network_Princess Margaret Cancer Centre /ID# 204539 | Toronto | Ontario | M5G 2M9 | Canada |
| The Chaim Sheba Medical Center /ID# 230812 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus /ID# 230813 | Haifa | 3109601 | Israel |
| National Cancer Center Hospital East /ID# 215130 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital /ID# 215003 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Maastricht Universitair Medisch Centrum /ID# 225220 | Maastricht | Limburg | 6229 HX | Netherlands |
| Antoni van Leeuwenhoek /ID# 222260 | Amsterdam | North Holland | 1066 CX | Netherlands |
| Erasmus Medisch Centrum /ID# 222341 | Rotterdam | South Holland | 3015 CE | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 222357 | Utrecht | 3584 CX | Netherlands |
| Pan American Center for Oncology Trials, LLC /ID# 232128 | Rio Piedras | 00935 | Puerto Rico |
| National Cancer Center /ID# 241095 | Goyang-si | Gyeonggido | 10408 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 240648 | Seoul | 03722 | South Korea |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 239997 | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre /ID# 239999 | Madrid | 28041 | Spain |
| National Taiwan University Hospital /ID# 205673 | Taipei City | Taipei | 100 | Taiwan |
| China Medical University Hospital /ID# 214062 | Taichung | 40447 | Taiwan |
| National Cheng Kung University Hospital /ID# 206304 | Tainan | 704 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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