Study of ABT-700 in Subjects With Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/22/2017 |
Start Date: | October 6, 2011 |
End Date: | June 29, 2017 |
A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors
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.
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.
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.
We found this trial at
6
sites
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10510 North 92nd Street
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
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