Ovarian Cancer Clinical Trial
Official title:
A Phase I Open-label Multicentre Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours
ALM201/0001 is a Phase I, open-label, dose-escalation study of the safety, tolerability and
pharmacokinetics (PK) of ALM201.
Part 1 will be a dose-escalation study. Patients with advanced solid tumours will receive
daily doses of ALM201 on Days 1-5, 8-12 and 15-19 in 21 day cycles.
Part 2 will be a dose-expansion of the Maximum Tolerated Dose (MTD) determined in Part 1.
Patients with advanced ovarian cancer will be enrolled with the main objective to determine
the recommended Phase II dose.
ALM201 is a peptide with anti-angiogenic activity in a range of in-vitro and ex-vivo models.
ALM201/0001 is a Phase I, multicentre, open-label, dose-escalation study of the safety,
tolerability and pharmacokinetics (PK) of ALM201. The study is divided into two parts.
Part 1 will enrol patients with advanced solid tumours. Patients will receive subcutaneous
injection of ALM201 on Days 1-5, 8-12 and 15-19 in 21 day cycles. Patients can receive up to
8 cycles of treatment. Enrolment will follow an accelerated dose-escalation schedule until
grade 2 drug-related adverse events are observed, at this point the 3+3 enrolment design will
be used. There will be at least 1 week stagger between the first and subsequent patients in a
new cohort dose. Dose increments will not exceed 100% escalation and will be guided by data
generated from previous cycles. The dose and possibly the schedule will be adjusted to
determine the Maximum Tolerated Dose (MTD).
Part 2 will enrol patients with advanced ovarian cancer whose tumour has a proangiogenic
profile as assessed by an angiogenesis gene signature biomarker. Patients will receive ALM201
at a dose and schedule established in Part 1.
Patients will undergo safety and tumour assessments as well as blood draws for PK profiling.
The safety assessments will involve physical examination, vital signs, biochemistry and
haematology laboratory screens as well as immunogenicity testing. Tumour assessments will
involve computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening and
after every 2 cycles during cycles 1 -8. Patients will be asked to provide consent for access
to archived tumour tissue and for fresh biopsies to be taken at pre-dose, tumour response
and/or point of disease progression for potential biomarker and pharmacodynamic assessments.
PK profiling will be carried out in Cycles 1, 2, 4, 6 and 8.
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