Advanced Solid Tumors Clinical Trial
Official title:
An Open Label, Single-Arm, Dose-Escalation Phase 1 Study of G-202 (Mipsagargin) in Patients With Advanced Solid Tumors
This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive days of a 28-day cycle in patients with advanced solid tumors. G-202 will be administered by intravenous infusion over 1 hour on Days 1, 2 and 3 of each 28-day cycle.
Pro-drug chemotherapy is an approach to cancer treatment that is being investigated as a
means to achieve higher concentrations of cytotoxic or biologically active agents at a tumor
location while avoiding systemic toxicity. With pro-drug chemotherapy, a relatively
non-toxic form of a cytotoxin, the pro-drug, is converted into the active cytotoxic agent at
the tumor site or other specific location. G-202 (mipsagargin) is a thapsigargin pro-drug;
it consists of a cytotoxic analog of thapsigargin coupled to a masking peptide which
inhibits its biologic activity until proteolytic cleavage at the tumor site. Thapsigargin is
a natural product with profound effects on cell viability. Thapsigargin is a non-cell-type
specific toxin with documented ability to kill a broad spectrum of cancer cell lines as well
as normal endothelial cells, fibroblasts and osteoblasts. It induces a rapid and pronounced
increase in the concentration of cytosolic calcium, due to blockade of the
Sarcoplasmic/Endoplasmic Reticulum Calcium ATPase (SERCA) pump to which it binds with high
affinity. The increase in cytosolic calcium leads to induction of apoptosis and ensuing cell
death.
The anti-tumor effect of G-202 in humans with advanced solid tumors is not yet known.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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