A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
2 other identifiers
interventional
61
4 countries
15
Brief Summary
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2016
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
November 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2019
CompletedJuly 20, 2020
July 1, 2020
2.9 years
November 2, 2016
July 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of participants with adverse events
First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
1 day of study drug administration within the 28-day cycle at the designated cohort dose
Area under the serum concentration-time curve (AUC) of ABBV-428
Up to 30 days after a 24-month treatment period
Terminal half-life (t1/2) of ABBV-428
Up to 30 days after a 24-month treatment period
Maximum observed serum concentration (Cmax) of ABBV-428
Up to 30 days after a 24-month treatment period
Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Up to 2 years
Time to Cmax (Tmax) of ABBV-428
Up to 30 days after a 24-month treatment period
Secondary Outcomes (4)
Duration of Objective Response (DOR)
Up to 30 days after a 24-month of treatment period
Clinical benefit rate (CBR)
Up to 30 days after a 24-month of treatment period
Progression-Free Survival (PFS)
Up to 30 days after a 24-month of treatment period
Objective Response Rate (ORR)
Up to 30 days after a 24-month of treatment period
Study Arms (4)
Arm 1
EXPERIMENTALABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
Arm A, B, and C
EXPERIMENTALAdditional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
Arm D
EXPERIMENTALAdditional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
Arm 2
EXPERIMENTALABBV-428 plus nivolumab.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
- Participants have adequate bone marrow, renal, hepatic and coagulation function.
- For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.
You may not qualify if:
- Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
- History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
- Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
- Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (15)
HonorHealth Research Institute - Pima /ID# 155461
Scottsdale, Arizona, 85258-2345, United States
UC Davis Comprehensive Cancer Center - Main /ID# 154439
Sacramento, California, 95817, United States
University of Chicago /ID# 154440
Chicago, Illinois, 60637-1443, United States
Fox Chase Cancer Center /ID# 170665
Philadelphia, Pennsylvania, 19111, United States
Greenville Hospital System /ID# 154437
Greenville, South Carolina, 29605, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 154441
Houston, Texas, 77030-4000, United States
South Texas Accelerated Research Therapeutics /ID# 154442
San Antonio, Texas, 78229, United States
Chris O'Brien Lifehouse /ID# 163131
Camperdown, New South Wales, 2050, Australia
Northern Cancer Institute /ID# 163132
St Leonards, New South Wales, 2065, Australia
Institut Bergonie /ID# 202391
Bordeaux, Gironde, 33000, France
Hopital de la Timone /ID# 162256
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
Centre Leon Berard /ID# 168072
Lyon, Rhone, 69373, France
Institut Curie /ID# 162258
Paris, Île-de-France Region, 75248, France
Gustave Roussy /ID# 162257
Villejuif, Île-de-France Region, 94805, France
National Taiwan Univ Hosp /ID# 169034
Taipei City, Taipei, 10002, Taiwan
Related Publications (1)
Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.
PMID: 33608377DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2016
First Posted
November 4, 2016
Study Start
November 18, 2016
Primary Completion
October 29, 2019
Study Completion
October 29, 2019
Last Updated
July 20, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share