OncoMatch/Clinical Trials/NCT06302621
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Is NCT06302621 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Afatinib and Pemigatinib for advanced solid tumor.
Treatment: Afatinib · Pemigatinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Cholangiocarcinoma
Biomarker criteria
Required: FGFR1 fusion
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR1 rearrangement
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR1 activating mutation
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR2 fusion
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR2 rearrangement
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR2 activating mutation
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR2 extracellular domain in-frame deletion
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR3 fusion
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR3 rearrangement
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR3 activating mutation
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions
Required: FGFR2 fusion
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion
Required: FGFR2 in-frame rearrangement
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion
Required: FGFR2 extracellular domain in-frame deletion
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion
Required: FGFR2 fusion
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy
Required: FGFR2 in-frame rearrangement
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy
Required: FGFR2 extracellular domain in-frame deletion
FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy
Excluded: FGFR2 activating mutation in the FGFR2 kinase domain
activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: FGFR inhibitor
Exception: Dose expansion cohort 1: No prior treatment with a selective FGFR inhibitor treatment
No prior treatment with a selective FGFR inhibitor treatment
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL (≥ 90 g/L); Absolute Neutrophil Count ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy
Kidney function
Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml/min
Liver function
ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases; Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN
Adequate organ function defined as: ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases; Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN; Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml/min; Hemoglobin ≥ 9 g/dL (≥ 90 g/L); Absolute Neutrophil Count ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06302621 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR1?
Yes, FGFR1 fusion is a required biomarker for enrollment.
Does this trial require FGFR1?
Yes, FGFR1 rearrangement is a required biomarker for enrollment.
Does this trial require FGFR1?
Yes, FGFR1 activating mutation is a required biomarker for enrollment.
Are patients with FGFR2 alterations eligible?
No. FGFR2 activating mutation in the FGFR2 kinase domain is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages