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NCT06777316 · ClinicalTrials.gov registry record · Phase 1

A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

A Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma (Icc), sponsored by Cogent Biosciences.

Recruiting
Registry status
Phase 1
Development phase
110
Enrollment target
15
Study locations

NCT06777316: Recruiting Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma (Icc), sponsored by Cogent Biosciences.

NCT06777316 is a Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma (Icc) that is actively recruiting participants, run by Cogent Biosciences. The registered enrollment target is 110 participants, below the 384-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (71% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06777316, a Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma (Icc), is actively recruiting participants, sponsored by Cogent Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
110 participants
Enrollment target
15
Study locations

Study Summary

This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.

Primary Outcome

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

Conditions Studied

Cholangiocarcinoma Intrahepatic Cholangiocarcinoma (Icc) Other Solid Tumors, Adult FGFR2 Gene Fusion/Rearrangement FGFR2 Gene Amplification FGFR2 Gene Short Variants FGFR3 Gene Fusion/Rearrangement FGFR3 Gene Amplification FGFR3 Gene Short Variants FGFR2 Genetic Alterations

Interventions

  • DRUG CGT4859

Study Locations (15)

Florida

  • Mayo Clinic Jacksonville - Jacksonville
  • Moffitt Cancer Center - Tampa

Ohio

  • The Christ Hospital - Cincinnati
  • Taussig Cancer Center - Cleveland Clinic - Cleveland

Arizona

  • Mayo Clinic Scottsdale - Scottsdale

California

  • Stanford Cancer Institute - Palo Alto

Illinois

  • University of Chicago Medicine Comprehensive Cancer Center - Chicago

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • Mayo Clinic Rochester - Rochester

Pennsylvania

  • Fox Chase cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2025-01-22
Est. Completion 2027-06
Phase Phase 1
Cogent Biosciences

12 total trials

What NCT06777316 shows while recruiting

NCT06777316 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 384-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (71% lower).

The record links to 10 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which CGT4859 is the first listed.

NCT06777316 lists 15 locations in 13 states (Florida, Ohio, Arizona).

Frequently Asked Questions

What is clinical trial NCT06777316 about?

NCT06777316 is a clinical study titled "A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors". This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid ...

What is the current status of trial NCT06777316?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2025-01-22. Estimated completion is 2027-06.

What conditions does trial NCT06777316 study?

This clinical trial studies the following conditions: Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc), Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification.

What interventions are being tested in trial NCT06777316?

The interventions under investigation include: CGT4859 (DRUG).

Who is sponsoring clinical trial NCT06777316?

This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06777316 being conducted?

This trial has 15 study locations across Arizona, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cholangiocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06777316's enrollment target sits among peer trials

110 30th of 60 higher than 30 of 60 other Cholangiocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06777316

Source: ClinicalTrials.gov NCT06777316, the US trial registry maintained by the National Library of Medicine. NCT06777316 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.