NCT01472016

Study of ABT-700 in Subjects With Advanced Solid Tumors

A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ABT-700	ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
DRUG	docetaxel	Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
DRUG	FOLFIRI	5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
DRUG	cetuximab	Cetuximab will be administered by intravenous infusion weekly.
DRUG	erlotinib	Erlotinib will be taken orally daily.
DRUG	ABT-700	ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.

Timeline

• Start date: 2011-10-06
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2011-11-16
• Last updated: 2017-11-21