A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

Phase 1 Completed 153 enrolled AbbVie

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.

Timeline

Start: 2017-03-20
Primary completion: 2022-01-21
Completion: 2022-01-21

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eftozanermin alfa	Protein / enzyme biologic	1.25 mg/kg	Intravenous
Subject	Eftozanermin alfa	Protein / enzyme biologic	2.5 mg/kg	Intravenous
Subject	Eftozanermin alfa	Protein / enzyme biologic	3.75 mg/kg	Intravenous
Subject	Eftozanermin alfa	Protein / enzyme biologic	7.5 mg/kg	Intravenous
Subject	Eftozanermin alfa	Protein / enzyme biologic	15 mg/kg	Intravenous
Subject	Venetoclax	Small molecule	400 mg	Oral
Subject	Venetoclax	Small molecule	800 mg	Oral
Background	Bevacizumab	Monoclonal antibody	—	Intravenous
Background	Irinotecan	Small molecule	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

Summary

Timeline

Publications

Drugs

Indications