NCT06302621

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label phase Ia/Ib study to evaluate safety, tolerability and preliminary efficacy of the combination of pemigatinib and afatinib in patients with FGFR-altered refractory advanced solid tumors. This study includes 2 parts: phase 1a dose escalation and phase 1b dose expansion. * In the phase 1a dose escalation study patients with FGFR-altered refractory advanced refractory solid tumors will be enrolled. * In the phase Ib dose expansion study, patients with FGFR-altered cholangiocarcinoma will be recruited into 2 cohorts: FGFR inhibitor-naïve cholangiocarcinoma and FGFR-inhibitor-pretreated and resistant cholangiocarcinoma. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves the study drugs Afatinib and Pemigatinib. Participants will receive study treatment for as long there is benefit and no unacceptable side effects. Participants will be followed for up to 1 year. It is expected that up to 70 people will take part in this research study. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved afatinib for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion. The FDA has not approved the combination of afatinib and pemigatinib as a treatment for any disease.

Conditions

• Advanced Solid Tumor
• Unresectable Solid Tumor
• Metastatic Solid Tumor
• Cholangiocarcinoma

Interventions

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

Timeline

• Start date: 2024-04-17
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-03-12
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study