RecruitingPhase 1Phase 2NCT06753747

A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma


Sponsor

West China Hospital

Enrollment

45 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if Afatinib plus Palbociclib works in previously treated recurrent or metastatic esophageal squamous cell carcinoma. It will also learn about the safety of the combination of Afatinib and Palbociclib. The main questions it aims to answer are: What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)? Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of afatinib (a targeted therapy that blocks the EGFR protein) and palbociclib (a drug that targets cancer cell growth cycle) in people with advanced esophageal squamous cell cancer (ESCC) that has the EGFR protein overexpressed and has progressed after prior treatments. **You may be eligible if...** - You are 18–75 years old with confirmed advanced or metastatic esophageal squamous cell cancer - Your cancer has the EGFR protein overexpressed or amplified (confirmed by testing) - Your disease has progressed after at least one prior line of treatment - You are in good health (ECOG 0–1) with adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer does not show EGFR overexpression (for the Phase 2 portion) - You are pregnant or breastfeeding - Your heart function (LVEF) is below 50% - You have certain blood count or organ function abnormalities outside required ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle.

DRUGAfatinib(30mg)

Afatinib will be administered orally at a dose of 30 mg once daily (QD) in each 4-week cycle.

DRUGAfatinib(40mg)

Afatinib will be administered orally at a dose of 40 mg once daily (QD) in each 4-week cycle.

DRUGAfatinib(RP2D)

In the Phase 2 study, the recommended Phase 2 dose (RP2D) of Afatinib, determined during the Phase 1b portion, will be utilized.


Locations(1)

West China Hospital

Chengdu, Sichuan, China

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NCT06753747


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