← Back to Search

Other

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 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of Objective Response (DOR)
Objective Response Rate (ORR)
+1 more

Trial 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

Find a Location

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
~17 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top