A Study of ABT-165 in Subjects With Solid Tumors

NCT01946074 ↗

Phase 1 Completed 101 enrolled AbbVie

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.

Timeline

Start: 2013-08-08
Primary completion: 2022-09-28
Completion: 2022-09-28

Publications

Gordon MS, Nemunaitis J, Barve M, Wainberg ZA, Hamilton EP, Ramanathan RK, Sledge GW Jr, Yue H, Morgan-Lappe SE, Blaney M, Kasichayanula S, Motwani M, Wang L, Naumovski L, Strickler JH. Phase I Open-Label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors. Mol Cancer Ther. 2021 Oct;20(10):1988-1995. doi: 10.1158/1535-7163.MCT-20-0985. Epub 2021 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budigalimab	Monoclonal antibody	—	Intravenous
Subject	Dilpacimab	Monoclonal antibody	1.25 mg/kg	Intravenous
Subject	Dilpacimab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	Irinotecan	Small molecule	—	Intravenous
Subject	Leucovorin	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous
Subject	fluorouracil	Small molecule	—	Intravenous

A Study of ABT-165 in Subjects With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications