Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator.
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined by testing routinely performed at a Clinical Laboratory Improvement Amendments (CLIA) or other similarly certified laboratory. If the FGFR alteration is present on circulating tumor DNA (ctDNA) analysis alone, the patient may be eligible with principal investigator approval. Additional mutations may be considered with principal investigator approval.
Eastern Cooperative Oncology Group (ECOG) 0-1.
At least 18 years of age.
Disqualifiers
Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib
For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs; activating mutations in the FGFR2 kinase domain seen on ctDNA or biopsy analysis prior to the 8-week timepoint may be allowed after discussion with the study PI.
Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib and afatinib.
Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful adverse events (AEs) can be made with input from the principal investigator.
Trial design
Treatments tested in this trial
- Afatinib
- Pemigatinib
Treatment groups
70 Participants
are divided into 3 treatment groupsLocations
1Massachusetts General Hospital02115, BostonMassachusetts, United States
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Boehringer Ingelheim
Collaborator
Incyte Corporation
Collaborator
Source ClinicalTrials.gov