Overview

This trial is active, not recruiting.

Condition advanced solid tumors
Treatments abt-700, docetaxel, folfiri, cetuximab, erlotinib
Phase phase 1
Targets c-MET, EGFR
Sponsor AbbVie (prior sponsor, Abbott)
Start date October 2011
End date October 2016
Trial size 124 participants
Trial identifier NCT01472016, M12-375

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
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.
(Experimental)
ABT-700 plus docetaxel.
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.
docetaxel
Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
(Experimental)
ABT-700 plus FOLFIRI/cetuximab
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.
folfiri
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
cetuximab
Cetuximab will be administered by intravenous infusion weekly.
abt-700
ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.
(Experimental)
ABT-700 plus erlotinib
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.
erlotinib
Erlotinib will be taken orally daily.

Primary Outcomes

Measure
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
time frame: First cycle of treatment through 60 day follow-up visit
To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
time frame: At each cycle of treatment through 60 days after last dose.
To determine the recommended Phase 2 dose for ABT-700
time frame: First cycle of treatment through 60 day follow-up visit

Secondary Outcomes

Measure
To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
time frame: Screening through 60 day follow-up visit

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification. - Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists. - Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage. - Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700. Exclusion Criteria: - Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700. - Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700. - Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia. - Subject has had major surgery within 21 days prior to the first dose of ABT-700. - Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.

Additional Information

Official title A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.