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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004953-57 | EudraCT Number |
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Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.
ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.
In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ABBV-637 Monotherapy | Experimental | Participants will receive escalating doses of ABBV-637 in 28-day cycles. |
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| Part 2a: ABBV-637 + Docetaxel | Experimental | Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles. |
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| Part 2b: ABBV-637 + Docetaxel | Experimental | Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles. |
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| Part 3a: ABBV-637 + Osimertinib | Experimental | Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles. |
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| Part 3b: ABBV-637 + Osimertinib | Experimental | Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-637 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. | Up to approximately 3 years |
| Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3) | ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) (Part 1) | ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute /ID# 231209 | Boston | Massachusetts | 02215 | United States | ||
| Washington University-School of Medicine /ID# 225698 |
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| Docetaxel | Drug | Intravenous (IV) Infusion |
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| Osimertinib | Drug | Oral Tablets |
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| Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1) |
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first. |
| Up to approximately 12 months |
| Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) | DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first. | Up to approximately 20 months |
| Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) | PFS is defined as the time from the first dose of any study drug to a documented radiographic disease progression according to RECIST version 1.1 as determined by the investigator, clinical progression or death from any cause, whichever occurs earlier. | Up to approximately 20 months |
| Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) | OS is defined as the time from the first dose of any study drug until death from any cause. | Up to approximately 12 months after last dose of study drug |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Carolina BioOncology Institute /ID# 225358 | Huntersville | North Carolina | 28078 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145 | Providence | Rhode Island | 02903-4923 | United States |
| South Texas Accelerated Research Therapeutics /ID# 225359 | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 225693 | Fairfax | Virginia | 22031 | United States |
| Wollongong Hospital /ID# 228350 | Wollongong | New South Wales | 2500 | Australia |
| Austin Health /ID# 225638 | Heidelberg | Victoria | 3084 | Australia |
| AP-HM - Hopital de la Timone /ID# 225779 | Marseille | Bouches-du-Rhone | 13385 | France |
| Institut Bergonie /ID# 225778 | Bordeaux | Gironde | 33000 | France |
| Institut Curie /ID# 225829 | Paris | Paris | 75248 | France |
| Centre Georges François Leclerc /ID# 226760 | Dijon | 21079 | France |
| Institut Claudius Regaud /ID# 225780 | Toulouse | 31052 | France |
| Rambam Health Care Campus /ID# 225586 | Haifa | H_efa | 3109601 | Israel |
| The Chaim Sheba Medical Center /ID# 225585 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| NHO Nagoya Medical Center /ID# 244412 | Nagoya | Aichi-ken | 460-0001 | Japan |
| National Cancer Center Hospital East /ID# 225725 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821 | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center /ID# 240761 | Fukuoka | Fukuoka | 811-1395 | Japan |
| National Cancer Center Hospital /ID# 225724 | Chuo-ku | Tokyo | 104-0045 | Japan |
| National Cancer Center /ID# 231887 | Goyang-si | Gyeonggido | 10408 | South Korea |
| Asan Medical Center /ID# 231886 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Samsung Medical Center /ID# 231888 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 233774 | Seoul | 03722 | South Korea |
| Hospital Universitario Vall d'Hebron /ID# 225976 | Barcelona | Barcelona | 08035 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 225975 | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre /ID# 225977 | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096 | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 225978 | Málaga | Malaga | 29010 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345 | Kaohsiung City | Kaohsiung | 807 | Taiwan |
| National Cheng Kung University Hospital /ID# 225944 | Tainan | Tainan | 704 | Taiwan |
| National Taiwan University Hospital - Hsinchu branch /ID# 243610 | Hsinchu | 30059 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 225946 | Taoyuan City | 333 | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C000596361 | osimertinib |
| 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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