Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224157

Enrollment

147

Registered

2018-11-22

Start date

2018-08-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Interventions

investigational material(s) Generic name etc : INCB054828 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed cholangiocarcinoma. 2) Radiographically measurable or evaluable disease per RECIST v1.1. 3) Tumor assessment for FGF/FGFR gene alteration status. 4) Documented disease progression after at least 1 line of prior systemic therapy. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6) Life expectancy >= 12 weeks.

Exclusion criteria

Exclusion criteria: 1) Prior receipt of a selective FGFR inhibitor. 2) History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. 3) Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. 4) Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.

Design outcomes

Primary

Measure	Time frame
efficacy Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (>= 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.	—

Secondary

Measure	Time frame
safety efficacy 1. ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 2. Progression-free survival based on RECIST v1.1 3. Safety and tolerability of INCB054828 as assessed by the frequency, duration, and severity of adverse events 1. ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (>= 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. 2. Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.	—

Measure

Time frame

safety efficacy 1. ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 2. Progression-free survival based on RECIST v1.1 3. Safety and tolerability of INCB054828 as assessed by the frequency, duration, and severity of adverse events 1. ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (>= 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. 2. Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026