Advanced Solid Tumors Clinical Trial
Official title:
A Phase I, Open-Label, Dose Escalation and Extension Study to Evaluate the Safety, Tolerability and Preliminary Effects of Oral BEL-X-HG in Patients With Advanced Refractory Solid Malignancies
This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).
This study will be carried out in 2 parts:
Part 1: A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose
escalation will be made based on dose-limiting toxicity (DLT), for a single cycle (28-days)
of BEL-X-HG treatment
Part 2: A Dose Extension Part of up to 5 cycles (28-days each) at the same dose level
(starting dose) of BEL-X-HG treatment
Approximately 24-48 eligible subjects with confirmed advanced refractory solid tumors will be
enrolled sequentially, in 3 subject cohorts, from the lower to the higher dose cohort into
the study. Escalating dose levels of BEL-X-HG in 4 study cohorts and one modified dose will
be as follows:
Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid)
Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid)
Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid)
Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid)
Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is
allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6
evaluable subjects of Dose level 2.
BEL-X-HG will be administered orally at the assigned dose level for a single cycle consisting
of 28 days during the Dose Escalation Part to each subject. Thereafter, if eligible and
willing, subjects can continue to Extension Part for 5 more cycles of treatment (each cycle
lasting 28 days), at the same assigned dose level of BEL-X-HG treatment.
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