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CGT4859

Phase 1

Intrahepatic Cholangiocarcinoma (Icc) | Small molecule | Oncology |Cogent Biosciences, Inc.|Last Updated: Apr 17, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical trial landscape

CGT4859 · 1 trial · 12 indications

Phase 1 1
NCT06777316A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid TumorsIntrahepatic Cholangiocarcinoma (Icc)
ACTIVE NOT_RECRUITING110 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
Intrahepatic Cholangiocarcinoma (Icc)
NCT06777316110
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Study Endpoints
Primary Endpoints
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
Approximately 12 months

Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results
Approximately 12 months

Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results
Approximately 12 months

Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters

Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Approximately 8 months
Secondary Endpoints
Phase 1: Pharmacokinetics
Approximately 28 days
Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Approximately 8 months
Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR)
Approximately 8 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1: Dose EscalationEXPERIMENTALMultiple doses of CGT4859 for oral administration
Phase 2: Signal SeekingEXPERIMENTALOral dose of CGT4859 at the RP2D as determined in Phase 1
Interventions
NameTypeDescription
CGT4859DRUGCGT4859 is a selective FGFR2/3 inhibitor
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor. 2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment. 3. Have measu...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06777316Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06777316studyFirstPostDate: changed