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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03595059
Registration number
NCT03595059
Ethics application status
Date submitted
12/07/2018
Date registered
23/07/2018
Titles & IDs
Public title
A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
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Scientific title
A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
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Secondary ID [1]
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2020-002495-12
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Secondary ID [2]
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M16-573
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-155
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Docetaxel
Experimental: Escalation 1a: ABBV-155 - Participants will be administered ABBV-155 (various doses).
Experimental: Escalation 1b: ABBV-155 + paclitaxel or docetaxel - Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Experimental: Expansion 2a: ABBV-155 in SCLC - Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
Experimental: Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer - 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.
Experimental: Expansion 2b: ABBV-155 + docetaxel in NSCLC - 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.
Treatment: Drugs: ABBV-155
Intravenous (IV) Infusion
Treatment: Drugs: Paclitaxel
Intravenous (IV) Infusion
Treatment: Drugs: Docetaxel
Intravenous (IV) Infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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MTD and/or RPTD of ABBV-155
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Assessment method [1]
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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).
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Timepoint [1]
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Up to approximately 21 days after initial dose of study drug
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Primary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 2 to 6 months
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Secondary outcome [1]
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Number of Participants with Adverse Events (AE)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 12 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 12 months
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Secondary outcome [3]
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Rate of Complete Response (CR)
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Assessment method [3]
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CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1
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Timepoint [3]
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Up to approximately 2 to 6 months
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 12 months
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as the number of days from the date of first study drug to the date of death due to any cause.
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Timepoint [5]
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Up to approximately 12 months after last dose of study drug
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Secondary outcome [6]
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Cmax of ABBV-155
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Assessment method [6]
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Maximum plasma concentration (Cmax).
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Timepoint [6]
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Up to approximately 48 days
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Secondary outcome [7]
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Tmax of ABBV-155
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Assessment method [7]
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Time to maximum plasma concentration (Tmax).
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Timepoint [7]
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Up to approximately 48 days
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Secondary outcome [8]
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Terminal Phase Elimination Rate constant of ABBV-155
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Assessment method [8]
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Terminal phase elimination rate constant of ABBV-155
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Timepoint [8]
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Up to approximately 48 days
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Secondary outcome [9]
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AUCt of ABBV-155
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Assessment method [9]
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Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).
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Timepoint [9]
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Up to approximately 48 days
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Secondary outcome [10]
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AUCinf of ABBV-155
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Assessment method [10]
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AUC from time 0 to infinite time (AUCinf).
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Timepoint [10]
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Up to approximately 48 days
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Secondary outcome [11]
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QTcF Change from Baseline
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Assessment method [11]
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QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.
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Timepoint [11]
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Up to approximately 8 days
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Secondary outcome [12]
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t1/2 of ABBV-155
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Assessment method [12]
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Terminal elimination half-life (t1/2).
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Timepoint [12]
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Up to approximately 48 days
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Eligibility
Key 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:
* Locally advanced or metastatic HR-positive/HER2-negative breast cancer after failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.
* HR-positivity and HER-2-negativity should be confirmed based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria.
* 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:
* No history of taxane allergy (Part 1b and Part 2b only).
* Disease that has relapsed or progressed at least 2 months after most recent exposure to any taxane-based therapy.
* Available tumor tissue suitable for immunohistochemistry testing.
* Adequate kidney, liver, and hematologic laboratory values as described in the protocol.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Untreated brain or meningeal metastases (participants with a history of metastases may be eligible based on details described in the protocol).
* Grade 2 or higher peripheral neuropathy (only applies to participants who would receive taxane therapy).
* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
* Known active infection of hepatitis B, hepatitis C, or human immunodeficiency virus with exceptions as described in the protocol.
* Recent history (within 6 months) of congestive heart failure (defined in the protocol), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
* Any history of hypersensitivity to any ingredients of ABBV-155 will be excluded. For combination therapy only (Parts 1b and 2b), no history of serious allergic reaction to any taxane or any ingredients used in taxane formulation (e.g., cremaphor).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
169
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Peter MacCallum Cancer Center /ID# 241676 - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arkansas
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California
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Canada
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Alberta
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Canada
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Ontario
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Israel
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H_efa
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Israel
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Tel-Aviv
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Japan
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Chiba
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Noord-Holland
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Maastricht
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Rotterdam
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Utrecht
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Rio Piedras
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03595059
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03595059