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Part 3A: 18F-AraG Imaging Substudy in TNBC Participants for Cancer
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Summary
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Eligible Conditions
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the serum concentration-time curve (AUC) of ABBV-368
Maximum observed serum concentration (Cmax) of ABBV-368
Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with ABBV-181
+5 moreSecondary outcome measures
Clinical benefit rate (CBR)
Duration of Objective Response (DOR)
Objective Response Rate (ORR)
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 3B: 18F-AraG Imaging Substudy in HNSCC ParticipantsExperimental Treatment2 Interventions
Part 3B: Additional participants (with HNSCC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
Group II: Part 3A: 18F-AraG Imaging Substudy in TNBC ParticipantsExperimental Treatment2 Interventions
Part 3A: Additional participants (with TNBC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
Group III: Part 2B: Combination Therapy Cohort ExpansionExperimental Treatment2 Interventions
Part 2B: Additional participants (with Head and Neck carcinoma) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W plus ABBV-181.
Group IV: Part 2A: Monotherapy Cohort ExpansionExperimental Treatment1 Intervention
Part 2A: Additional participants (triple negative breast cancer \[TNBC\]) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W.
Group V: Part 1A: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part 1A: ABBV-368 (various dose levels) intravenous administration every 2 weeks (Q2W). One cycle of treatment is 28 days, thus there will be 2 doses with ABBV-368 per cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-368
2017
Completed Phase 1
~170
ABBV-181
2013
Completed Phase 1
~500
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Who is running the clinical trial?
AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,595 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
155,959 Total Patients Enrolled
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