NCT06947811

A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations

A Multicenter, Open-Label, Single-Arm, Phase Ib/II Clinical Study of Almonertinib Combined With Palbociclib in the Treatment of Patients With KRAS Mutations-Positive Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and tolerability of almonertinib combined with palbociclib in patients with advanced solid tumors harboring KRAS gene mutations, and to conduct a preliminary observation of its efficacy

Detailed description

The main purpose of this study is to evaluate the safety and tolerability of almonertinib combined with palbociclib in patients with advanced solid tumors harboring KRAS gene mutations, and to conduct a preliminary observation of its efficacy

Conditions

• EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor

Interventions

Type	Name	Description
DRUG	Almonertinib	Patients will be treated with Almonertinib, 110 mg p.o., daily
DRUG	Palbociclib	Patients will be treated with Palbociclib, 125 mg(dose determined from Part one of study) p.o., daily

Timeline

• Start date: 2025-06-09
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-04-27
• Last updated: 2025-06-04

Locations

1 site across 1 country: China