18 and older, any sex, with Advanced or Metastatic Solid Tumor or Advanced or Metastatic Gastric or Gastroesophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and BPrimary· At the end of every 2 cycles until disease progression (Up to 31 months)
ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the
Group
Value
95% CI
Futibatinib (Cohort A)
6.9
2.6 – 14.4
Futibatinib (Cohort B)
17.9
6.1 – 36.9
ORR Based on Investigator Assessment in Cohorts A and BSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
ORR was defined as the percentage of participants experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages wer
Group
Value
95% CI
Futibatinib (Cohort A)
9.2
4.1 – 17.3
Futibatinib (Cohort B)
10.7
2.3 – 28.2
Duration of Response (DOR) Based on IRC in Cohorts A, B and CSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Futibatinib (Cohort A)
5.6
3.5 – NA
Futibatinib (Cohort B)
3.9
2.1 – NA
DOR Based on Investigator Assessment in Cohorts A, B and CSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Futibatinib (Cohort A)
5.6
3.0 – NA
Futibatinib (Cohort B)
5.6
2.0 – NA
Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and CSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Group
Value
95% CI
Futibatinib (Cohort A)
1.9
1.8 – 3.5
Futibatinib (Cohort B)
2.9
1.8 – 3.7
PFS Based on Investigator Review in Cohorts A, B and CSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Group
Value
95% CI
Futibatinib (Cohort A)
3.3
1.9 – 3.8
Futibatinib (Cohort B)
3.3
2.1 – 3.7
Overall Survival (OS) in Cohorts A, B and CSecondary· Up to 31 months
OS was defined as the time from the date of first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.
Group
Value
95% CI
Futibatinib (Cohort A)
11.1
7.3 – 15.6
Futibatinib (Cohort B)
5.9
3.9 – 8.9
Disease Control Rate (DCR) Based on IRC in Cohort A and BSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
DCR was defined as the percentage of participants experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pat
Group
Value
95% CI
Futibatinib (Cohort A)
37.9
27.7 – 49.0
Futibatinib (Cohort B)
50.0
30.6 – 69.4
DCR Based on Investigator Review in Cohort A and BSecondary· At the end of every 2 cycles until disease progression (Up to 31 months)
DCR was defined as the percentage of participants experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reductio
Group
Value
95% CI
Futibatinib (Cohort A)
52.9
41.9 – 63.7
Futibatinib (Cohort B)
64.3
44.1 – 81.4
Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and CSecondary· From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug, and does not necessarily have a causal relationship to the use of the study drug.
Group
Value
95% CI
Futibatinib (Cohort A)
87
Futibatinib (Cohort B)
27
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug up to 30 days after the last dose (Up to 31 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Futibatinib (Cohort A)
Serious: 23/87 (26%)
Deaths: 54/87
Futibatinib (Cohort B)
Serious: 6/28 (21%)
Deaths: 24/28
Serious adverse events (36 terms)
Reaction
System
Futibatinib (Cohort A)
Futibatinib (Cohort B)
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
General physical health deterioration
General disorders
—
—
COVID-19
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Eyelid ptosis
Eye disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Subileus
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Fatigue
General disorders
—
—
Hepatic failure
Hepatobiliary disorders
—
—
Device related infection
Infections and infestations
—
—
Escherichia sepsis
Infections and infestations
—
—
Blood lactic acid increased
Investigations
—
—
General physical condition abnormal
Investigations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
—
—
Cerebrovascular accident
Nervous system disorders
—
—
Ischaemic stroke
Nervous system disorders
—
—
Calculus urinary
Renal and urinary disorders
—
—
Haematuria
Renal and urinary disorders
—
—
Other adverse events (213 terms — click to expand)
The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma \[iCCA\]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06263153 — Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patie
· Phase 2
· recruiting
NCT05827614 — Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With
· Phase 1
· active not recruiting
NCT05036681 — A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
· Phase 2
· terminated
NCT04828486 — Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer
· Phase 2
· completed
NCT04601857 — Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Taiho Oncology, Inc.
Last refreshed: 8 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04189445.