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Tyrosine Kinase Inhibitor

Afatinib + Pemigatinib for Solid Tumors

Phase 1

Recruiting

Led By Haley Ellis, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 9 weeks during treatment and off study up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination of two drugs, Afatinib and Pemigatinib, is safe and effective for treating certain types of advanced solid tumors with specific genetic mutations. The study

Who is the study for?

This trial is for individuals with advanced solid tumors that can't be removed by surgery or have spread (metastatic), and whose tumors have specific genetic alterations called FGFR. The exact eligibility criteria are not provided, but typically participants must meet certain health standards to ensure safety.

What is being tested?

The study is testing the combination of two drugs, Afatinib and Pemigatinib, to see if they're safe and effective against advanced solid tumors with FGFR alterations. It also aims to find the highest doses patients can take without severe side effects.

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like Afatinib and Pemigatinib may include diarrhea, skin issues, mouth sores, loss of appetite, fatigue, nail changes, and potential liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 9 weeks during treatment and off study up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 9 weeks during treatment and off study up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 9 weeks during treatment and off study up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Objective response rate (ORR)

Secondary study objectives

Best Overall Response

Disease Control Rate

Duration of Response

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: DOSE ESCALATION PHASE 1A PEMIGATINIB + AFATINIBExperimental Treatment2 Interventions

In the phase 1a dose escalation study participants with FGFR-altered refractory advanced solid tumors will be enrolled. This research study involves the study drugs Afatinib and Pemigatinib.

Group II: COHORT 2: EXPANSION PHASE 1B COHORT 2 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-PRETREATEDExperimental Treatment2 Interventions

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. Cohort 2 will enroll patients with FGFR-inhibitor-pretreated and resistant cholangiocarcinoma. This research study involves the study drugs Afatinib and Pemigatinib.

Group III: COHORT 1: EXPANSION PHASE 1B COHORT 1 MTD/RP2D PEMIGATINIB + AFATINIB FGFR INHIBITOR-NAIVEExperimental Treatment2 Interventions

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. Cohort 1 will enroll patients with FGFR inhibitor-naïve cholangiocarcinoma. This research study involves the study drugs Afatinib and Pemigatinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemigatinib

2022

Completed Phase 2

~300

Afatinib

2016

Completed Phase 4

~2330