NCT05605509

RP-6306 in Patients With Advanced Cancer

A Phase II Study of RP-6306 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	RP-6306	Dose and schedule will be assigned at enrolment
DRUG	Gemcitabine	Dose and schedule will be assigned at enrolment
DRUG	FOLFIRI Protocol	Irinotecan Leucovorin FU
DRUG	Trastuzumab	standard doses q3weekly
DRUG	RP-3500	Dose and schedule will be assigned at enrolment

Timeline

• Start date: 2023-05-24
• Primary completion: 2025-11-14
• Completion: 2026-02-05
• First posted: 2022-11-04
• Last updated: 2026-02-06

Locations

6 sites across 1 country: Canada