Colorectal Cancer Clinical Trial
Official title:
A Phase 1b Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma
The purpose of this trial is to evaluate changes in immune activity relative to baseline
following treatment with Toca 511 and Toca FC in patients with solid tumors (including
recurrent high grade glioma [rHGG]) or lymphoma. This is a multicenter, open-label study of
Toca 511 and Toca FC. Patients with advanced solid tumors or lymphoma, for whom curative
options are not available, will be enrolled into the study, subject to all entry criteria.
Tumors must be accessible to biopsy and/or resection. Patients will be qualified based on the
presence of specific molecular characteristics, documented by Foundation Medicine (or
equivalent) genomic profile report, and specific tumor types.
Toca 511 will be administered by IV injection followed by (1) intratumoral injection
following biopsy or (2) injection into the resection cavity wall following planned resection
in the case of rHGG or brain metastases. Toca FC will be administered orally in cycles of
therapy.
Patients not undergoing resection of brain tumors will undergo 2 biopsies to allow assessment
of baseline and follow-up immune activity in the tumor. Changes in immune activity in
peripheral blood will be measured in all patients.
n/a
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