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Monoclonal Antibodies

ABT-165 for Solid Tumors

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 30 days after a 24-month treatment period
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating advanced solid tumors.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after a 24-month treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after a 24-month treatment period 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 curve (AUC) form time zero to the last measurable concentration AUC (0-t)
Cardiac assessment
Clinical lab testing
+5 more
Secondary outcome measures
Duration of overall response (DOR)
Objective response rate (ORR)
Progression free survival (PFS)

Trial Design

5Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment1 Intervention
ABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165
Group II: Cohort DExperimental Treatment3 Interventions
ABT-165 plus ABBV-181 plus paclitaxel
Group III: Cohort CExperimental Treatment2 Interventions
ABT-165 plus ABBV-181
Group IV: Cohort BExperimental Treatment2 Interventions
ABT-165 plus FOLFIRI
Group V: Cohort AExperimental Treatment2 Interventions
ABT-165 plus paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
paclitaxel
1996
Completed Phase 3
~4310
FOLFIRI
2005
Completed Phase 3
~5860
ABT-165
2013
Completed Phase 1
~110
ABBV-181
2013
Completed Phase 1
~500

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,283 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,997 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Molecular Cancer TherapeuticsJournal
Phase I Open-label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors
Gordon, Michael S., John Nemunaitis, Minal Barve, Zev A. Wainberg, Erika P. Hamilton, Ramesh K. Ramanathan, George W. Sledge Jr, et al.. 2021. “Phase I Open-label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-20-0985.
clinicaltrials.govStudy
A Study of ABT-165 in Subjects With Solid Tumors
2013. "A Study of ABT-165 in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01946074.
~9 spots leftby Apr 2025
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