Study of ABT-700 in Subjects With Advanced Solid Tumors

NCT01472016 | Completed Phase 1

• 1 other identifier: M12-375
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

c-Met overexpression; MET amplification; Neoplasms; h224G11

Outcome Measures

Primary Outcomes (3)

• 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

  Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring

  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

  Pharmacokinetic profile of ABT-700 analyzed from blood samples

  At each cycle of treatment through 60 days after last dose.

• To determine the recommended Phase 2 dose for ABT-700

  First cycle of treatment through 60 day follow-up visit

Secondary Outcomes (1)

• 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

  Screening through 60 day follow-up visit

Study Arms (4)

Cohort A

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.

Drug: ABT-700

Cohort B

EXPERIMENTAL

ABT-700 plus docetaxel.

Drug: ABT-700; Drug: docetaxel

Cohort C

EXPERIMENTAL

ABT-700 plus FOLFIRI/cetuximab

Drug: ABT-700; Drug: FOLFIRI; Drug: cetuximab

Cohort D

EXPERIMENTAL

ABT-700 plus erlotinib

Drug: ABT-700; Drug: erlotinib

Interventions

ABT-700 DRUG

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.

Cohort A; Cohort B; Cohort C; Cohort D

docetaxel DRUG

Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.

Cohort B

FOLFIRI DRUG

5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.

Cohort C

cetuximab DRUG

Cetuximab will be administered by intravenous infusion weekly.

Cohort C

erlotinib DRUG

Erlotinib will be taken orally daily.

Cohort D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

MeSH Terms

Conditions

Neoplasms

Interventions

telisotuzumab vedotin; Docetaxel; IFL protocol; Cetuximab; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Louie Naumovski, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 16, 2011
• Study Start: October 6, 2011
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-06