This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given
rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not
been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days
to establish the maximum tolerated dose (MTD) of the combination of NOX66 and
doxorubicin.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05100628.
The study will contain dose-escalation cohorts and dose-expansion cohorts. The study
design allows an exploration of different doses of NOX66 with safety monitoring to ensure
the safety of the patients.
Dose-escalation cohorts: It will include three planned Treatment Groups (800, 1200, 1800
mg daily) and patients enrolled in these groups will receive 7 days of monotherapy
treatment with NOX66 followed by a 5-day washout period. Thereafter, patients will enter
a combination therapy (only if no significant toxicity is observed during monotherapy).
This will commence with Cycle 1, which will consist of 7 days of NOX66, and on Day 2 of
the 21-day cycle, doxorubicin will be administered. Patients will continue to be treated
for up to 6 x 21-day cycles of NOX66 and doxorubicin. New patients will be entered at the
next dose level of NOX66, if no dose-limiting toxicities have occurred among the first 3
patients at the end of cycle 1. During the dose-escalation, MTD of the combination of
NOX66 and doxorubicin will be determined.
Dose-expansion cohort: On completion of the dose-escalation cohort, patients will be
enrolled into a dose-expansion at the MTD of the combination of NOX66 and doxorubicin.
All patients will enter directly into 21-day combination cycles and will be given NOX66
therapy for 7 days and doxorubicin will be administered on Day 2 of each cycle. Treatment
will be terminated upon disease progression, unacceptable toxicity, or a maximum of 6
cycles.
Lead OrganizationNoxopharm Limited
