drugset / Trial / NCT06243185

Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors

NCT06243185

Phase 2 Unknown 30 enrolled Fengzhi Feng
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant recurrent HR-positive, HER2-negative gynecologic solid tumors." Dalpiciclib is a CDK4/6 kinase inhibitor that selectively inhibits the activity of CDK4/6 kinase, so that the complex with Cyclin D cannot phosphorylate the downstream Rb protein and prevent cells from entering the S phase from G1 phase, thereby inhibiting cell proliferation and anti-tumor effects.

Timeline

Start
2023-11-17
Primary completion
2024-12-31
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 150 mg
Subject Letrozole Other / unclassified 2.5 mg

Indications