Solid Tumor, Adult Clinical Trial
Official title:
An Open Label Ascending Dose Study Evaluating the Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of KA2507 in Patients With Solid Tumours
The aim of the study is to evaluate the safety/tolerability, pharmacokinetic, and
pharmaco-dynamic effects of KA2507 and establish the maximum tolerated dose (MTD). Patients
with PD-L1 expressing solid tumors which have relapsed or are refractory to prior treatment
will be eligible to participate in this study.
Following completion of the multiple ascending dose study, the protocol may be amended to
include expansion cohorts in patients with melanoma and/or other solid tumors.
The aim of the study is to evaluate the safety/tolerability, pharmacokinetic, and
pharmaco-dynamic effects of KA2507 and establish the maximum tolerated dose (MTD). Patients
with PD-L1 expressing solid tumors which have relapsed or are refractory to prior treatment
will be eligible to participate in this study.
Following completion of the multiple ascending dose study, the protocol may be amended to
include expansion cohorts in patients with melanoma and/or other solid tumors.
This is a multiple ascending dosing (MAD) study of up to 6 treatment regimens cohorts based
on using a 3+3 design (up to 36 patients overall). The principal objective is to establish
the maximum tolerated dose, safety, tolerability and pharmacokinetic (PK) profile in blood
and urine of this HDAC6 inhibitor in patients with solid tumors and to explore effects on
pharmacodynamic markers of target engagement and response to treatment.
Daily/twice daily doses will be given as open label monotherapy. A review of safety and PK
data will be conducted once the last patient in each cohort reaches day 28 of treatment. The
review will confirm the dose to be used for the subsequent cohort. Dose escalation will be
continued until the MTD is reached. Upon completion of the dose escalation phase of the
study, dose expansion phases will be planned.
Patients responding to treatment may elect to remain on therapy until disease progression,
death or the investigator decides to stop treatment.
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