Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open-label, single dose level study of PRL3-ZUMAB monotherapy in patients
with advanced solid tumours that have failed standard therapy. Approximately 30 patients will
be recruited with ~10 gastric cancers and ~10 hepatocellular carcinomas. Patients who have
received at least 1 dose of PRL3-ZUMAB will be evaluable for toxicity and efficacy.
PRL3-ZUMAB will be given IV every 2 weeks for up to 12 infusions in the absence of
unmanageable toxicities or disease progression. Patients who are benefitting from the
treatment may continue on PRL3-ZUMAB beyond 12 infusions with the agreement of the study drug
provider.
PRL3-ZUMAB at the RP2D in tumour types enriched for known PRL-3 expression for efficacy and
tolerability will be evaluated. There will also be in depth molecular profiling of tissues in
patients who have an objective response or prolonged disease stabilization to identify
predictive/selection biomarkers as well as evaluation of the oncogenic signaling modulation
and immunomodulation by PRL3-ZUMAB and its potential for future combination with other
targeted therapies or immunotherapy.