Cancer Clinical Trial
Official title:
A Phase 1 Study of PTC596 in Patients With Advanced Solid Tumors
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic (PK) study of
PTC596 in patients with advanced cancer. A variation of the traditional 3+3 dose escalation
design will be employed.
PTC596 will be administered orally on a twice a week (biw) schedule. Each 4-week period of
drug administration will be considered one cycle. The objective of the study will be to
determine the recommended Phase 2 dose (RP2D) and to determine preliminary proof of mechanism
of action.
Collectively, data from the Good Laboratory Practice (GLP) and non-GLP studies indicate that
40 mg/kg biw is approximately the severely toxic dose in 10% of animals (STD 10). Therefore,
the starting dose in this study will be calculated as one-tenth of the human equivalent dose
(HED) of 40 mg/kg biw in rats, which is 0.65 mg/kg biw.
In this study, escalating dose levels will be evaluated to determine the RP2D. Three patients
will be enrolled at the starting dose level (0.65 mg/kg biw); if 1 of the 3 patients
experiences a dose-limiting toxicity (DLT), an additional 3 patients will be enrolled at the
same dose level. Thus, 3 to 6 patients will receive the starting dose level of 0.65 mg/kg.
Dose escalation will continue until the occurrence of DLT in ≥2/6 patients at a given dose
level. Dose escalation will occur in approximately 100% increments until Grade ≥2,
first-cycle toxicity is seen in at least 2 patients across all dose levels, after which dose
escalation will occur in smaller (50% or 33%) increments.
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