Actively Recruiting
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Led by Massachusetts General Hospital · Updated on 2026-01-15
70
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Unresectable or metastatic advanced solid tumor confirmed by tissue testing and no longer responding to standard treatments or not suitable for them
- FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions confirmed by tumor profiling or circulating tumor DNA with investigator approval
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to swallow tablets
- Life expectancy of at least 3 months
- Willingness and ability to comply with outpatient treatment, lab monitoring, and clinic visits during study participation
- For cholangiocarcinoma patients, adequate biliary drainage without infection
- Men and women of reproductive potential agree to use effective birth control during treatment and for 3 months after
- Measurable or non-measurable disease as per RECIST 1.1 criteria
- Adequate organ function based on liver enzymes, bilirubin, kidney function, blood counts, and coagulation tests as specified
- Dose expansion cohort 1: confirmed advanced or metastatic cholangiocarcinoma, no prior FGFR inhibitor treatment, FGFR2 fusion or related alterations confirmed by tumor profiling, availability of tumor tissue sample or agreement to biopsy
- Dose expansion cohort 2: confirmed advanced or metastatic cholangiocarcinoma, prior FGFR inhibitor treatment with documented clinical benefit, FGFR2 fusion or related alterations confirmed, availability of tumor tissue sample or agreement to biopsy
You will not qualify if you...
- Known allergy to afatinib, pemigatinib, or pemigatinib ingredients
- For prior FGFR inhibitor-treated patients, known activating FGFR2 kinase domain mutations within 8 weeks before study start
- Recent systemic or liver-directed anticancer therapy within 2 weeks or monoclonal antibody within 4 weeks before treatment
- Unresolved side effects from prior therapy above grade 1 unless non-clinically meaningful
- Major surgery within 4 weeks before treatment (excluding tumor biopsy, biliary stent/catheter, feeding tube)
- Recent radiation therapy within 2 to 4 weeks before treatment with unresolved effects
- Known pre-existing interstitial lung disease
- Vitamin D deficiency requiring high dose supplements
- Significant disorders affecting calcium or phosphorus balance
- Significant eye disorders confirmed by eye exam
- Moderate to severe liver cirrhosis (Child-Pugh B or C)
- Significant chronic nausea, vomiting, or diarrhea
- Malabsorption conditions affecting drug absorption
- History of other primary cancers currently active or requiring treatment except certain hormonal therapies
- History of hepatic encephalopathy
- Ascites requiring repeated drainage
- Active brain metastases or leptomeningeal disease; stable treated brain metastases allowed
- Significant active heart disease including uncontrolled hypertension and recent heart attack
- Prolonged QT interval or related heart rhythm disorders
- Active uncontrolled infections or diseases making participation unsafe
- Active hepatitis B unless controlled with antiviral therapy and low viral load
- HIV infection on antiretroviral therapy
- Active drug or alcohol abuse
- Use of strong p-gp inhibitors or certain CYP3A4 inhibitors or inducers shortly before treatment
- Pregnant or breastfeeding women or those unwilling to use contraception
- Unable to swallow pills
- Any other serious illness or condition that may affect safety or study evaluation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
H
Haley Ellis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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