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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
14/08/2024

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
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
Secondary ID [1] 0 0
2020-004953-57
Secondary ID [2] 0 0
M20-111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Cancer 0 0
Non Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response Rate (ORR) (Part 1)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
Timepoint [2] 0 0
Up to approximately 12 months
Secondary outcome [3] 0 0
Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Timepoint [3] 0 0
Up to approximately 20 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Timepoint [4] 0 0
Up to approximately 20 months
Secondary outcome [5] 0 0
Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3)
Timepoint [5] 0 0
Up to approximately 12 months after last dose of study drug

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Wollongong Hospital /ID# 228350 - Wollongong
Recruitment hospital [2] 0 0
Austin Health /ID# 225638 - Heidelberg
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
France
State/province [7] 0 0
Bouches-du-Rhone
Country [8] 0 0
France
State/province [8] 0 0
Gironde
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
Israel
State/province [12] 0 0
H_efa
Country [13] 0 0
Israel
State/province [13] 0 0
Tel-Aviv
Country [14] 0 0
Japan
State/province [14] 0 0
Aichi
Country [15] 0 0
Japan
State/province [15] 0 0
Chiba
Country [16] 0 0
Japan
State/province [16] 0 0
Ehime
Country [17] 0 0
Japan
State/province [17] 0 0
Fukuoka
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Gyeonggido
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul Teugbyeolsi
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Malaga
Country [25] 0 0
Taiwan
State/province [25] 0 0
Keelung
Country [26] 0 0
Taiwan
State/province [26] 0 0
Hsinchu City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04721015
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04721015