RecruitingPhase 1NCT06302621

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

A Phase Ia/Ib Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors


Sponsor

Massachusetts General Hospital

Enrollment

70 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors. The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects. This research study involves the study drugs Afatinib and Pemigatinib.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — pemigatinib (which blocks an abnormal growth signal called FGFR) and afatinib (which blocks another growth signal called EGFR/HER) — in people with advanced solid tumors that have stopped responding to standard treatments and have specific genetic changes in the FGFR gene. **You may be eligible if...** - You have an advanced or metastatic solid tumor (any cancer type) that cannot be surgically removed - Standard treatments are no longer working or are not appropriate for you - Your tumor has an FGFR1–3 fusion, rearrangement, activating mutation, or specific FGFR2 change confirmed by a certified lab test - You are in good general health (ECOG score 0–1) **You may NOT be eligible if...** - Standard treatments with a meaningful chance of benefit are still available and appropriate for you - You have serious eye, heart, liver, or lung conditions - You are pregnant or breastfeeding - You have received prior FGFR-targeted therapy that caused you to stop treatment due to toxicity 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

DRUGAfatinib

Each study treatment cycle lasts 21 days: Afatinib, oral, once daily, per protocol determined number of days per cycle and per protocol determined dosage

DRUGPemigatinib

Each study treatment cycle lasts 21 days: Pemigatinib, oral, once daily, per protocol determined number of days per cycle and per protocol determined dosage


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06302621


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