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Brief Title: RP-6306 in Patients With Advanced Cancer
Official Title: A Phase II Study of RP-6306 in Patients With Advanced Cancer
Study ID: NCT05605509
Brief Summary: This study is being done to answer the following questions: * Is the new drug, RP-6306, safe to use, and what effects does it have on cancer when given with standard treatment? * If there are specific biomarkers, do patients have an improved response to treatment compared to those without the biomarker? This study is being done to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for this type of cancer.
Detailed Description: RP-6306 is a PKMYT1 inhibitor. PKMYT1 protein kinase negatively regulates CDK1 via phosphorylation of threonine 14 (Thr14) and sequestration in the cytoplasm. RP-6306 has shown single-agent anti-tumour efficacy in several xenograft models with amplified CCNE1 in a dose-dependent manner. RP-6306 has synergistic effects in combination with gemcitabine in CCNE1-amplified/overexpressing models in vitro and in vivo
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Name: Stephanie Lheureux
Affiliation: University Health Network, Princess Margaret Hospital, Toronto ON Canada
Role: STUDY_CHAIR
Name: Yvette Drew
Affiliation: BCCA-Vancouver Cancer Centre, Vancouver BC Canada
Role: STUDY_CHAIR
Name: Eric Chen
Affiliation: University Health Network, Princess Margaret Hospital, Toronto ON Canada
Role: STUDY_CHAIR