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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04721015
Registration number
NCT04721015
Ethics application status
Date submitted
20/01/2021
Date registered
22/01/2021
Date last updated
18/06/2024
Titles & IDs
Public title
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
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Scientific title
A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
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Secondary ID [1]
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2020-004953-57
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Secondary ID [2]
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M20-111
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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 Cancer
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Non Small Cell Lung Cancer (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-637
Treatment: Drugs - Docetaxel
Treatment: Drugs - Osimertinib
Experimental: Part 1: ABBV-637 Monotherapy - Participants will receive escalating doses of ABBV-637 in 28-day cycles.
Experimental: Part 2a: ABBV-637 + Docetaxel - Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
Experimental: Part 2b: ABBV-637 + Docetaxel - Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
Experimental: Part 3a: ABBV-637 + Osimertinib - Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
Experimental: Part 3b: ABBV-637 + Osimertinib - Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.
Treatment: Drugs: ABBV-637
Intravenous (IV) Infusion
Treatment: Drugs: Docetaxel
Intravenous (IV) Infusion
Treatment: Drugs: Osimertinib
Oral Tablets
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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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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [1]
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Percentage of Participants With Objective Response Rate (ORR) (Part 1)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
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Assessment method [2]
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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.
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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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Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 20 months
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Secondary outcome [4]
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Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 20 months
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Secondary outcome [5]
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Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
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Assessment method [5]
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OS is defined as the time from the first dose of any study drug until death from 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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Eligibility
Key inclusion criteria
* Histologic solid tumor diagnosis (Part 1).
* For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
* For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* For Part 1 only - history of R/R disease that has progressed on all standard of care therapy.
* For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
* For Part 3 only - history of RR NSCLC that has progressed on osimertinib
* Meet the laboratory values as described in the protocol.
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Minimum age
18
Years
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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
* History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
* For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
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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
23/02/2021
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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
30/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
81
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Wollongong Hospital /ID# 228350 - Wollongong
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Recruitment hospital [2]
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Austin Health /ID# 225638 - Heidelberg
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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Virginia
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France
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Bouches-du-Rhone
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France
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Gironde
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France
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Paris
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France
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Dijon
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France
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Toulouse
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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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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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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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Korea, Republic of
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Seoul
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Malaga
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Taiwan
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Hsinchu City
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taoyuan 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
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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Trial website
https://clinicaltrials.gov/study/NCT04721015
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04721015
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