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ongoing
clinical trials
The first sequence of the ongoing phase II open label trial, which
evaluated the effects of  I-TM601
at escalating doses in 15 patients with high-grade glioma, was
completed in 2006. The larger, second phase of this study was
designed to evaluate the effects of I-TM601
at a fixed dose of 40 mCi/0.8 mg TM601 administered through an
intercavitary device for either 3 or 6 treatment cycles.
The primary endpoints are overall time to
disease progression at 6 and 12 months, and survival rates. The
study will also evaluate quality of life and uptake/distribution
of I-TM601.
The study has recently completed enrollment and is currently ongoing.
This study includes patients with metastatic tumors affecting
the brain or other areas of the body that are non-responsive to
standard therapy. The objectives of the study are to:
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Evaluate whether I.V.
administration of I-TM601
locally targets primary and metastatic tumor cells in the
brain and elsewhere in the body. |
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Determine the uptake and distribution
of I-TM601
after I.V. administration. |
| • |
Determine the safety and tolerability
of intravenously administered I-TM601. |
To achieve the study objectives, patients will undergo
dosimetry studies and whole body scans after receiving 2 to 3
escalating doses of I-TM601
and will be evaluated for adverse events. The study is currently
enrolling patients. For more information about patient enrollment,
click here.
This study will further evaluate the
biodistribution and clearance of I
after multiple intracavitary doses of I-TM601
in up to five patients participating in the second sequence of
the TM601-002 high-grade glioma clinical trial. Dosimetry will
be performed following the first, third and sixth injections of
I-TM601
to determine the uptake and elimination of I
in the tumor cavity and normal organ tissue.
TransMolecular has recently initiated an investigational study to investigate unlabeled TM601. Pre-clinical studies have indicated that IV-administered, unlabeled TM601 has antitumor effects of its own, potentially due to antiangiogenic activity. TransMolecular will be conducting the clinical study to evaluate the effects of unlabeled TM601 alone in the treatment of patients with progressive and/or recurrent high-grade glioma.
The purpose of this phase 1 clinical trial is to evaluate the safety and define the biologically active IV dose of TM601 in patients with treatment-refractory, malignant glioma. A single intravenous “imaging” dose of I-TM601 will be administered prior to treatment with TM601. Only patients demonstrating tumor specific uptake of I-TM601 will receive further treatment. Those patients will receive intravenous infusions at one of six dose levels (0.04 mg/kg, 0.08 mg/kg, 0.16 mg/kg, 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg) once a week for 3 weeks. Patients will be enrolled in successive dose cohorts until either a Maximum Tolerated Dose (MTD) is defined, or perfusion changes have been demonstrated in 5 out of 6 patients in a cohort. The study is expected to take up to 18 months to complete.
For information about future clinical development, click
here.
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