Intrahepatic Cholangiocarcinoma (Icc)Phase 1/2NCT06777316
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
A Phase 1/2 study testing CGT4859 in people with Intrahepatic Cholangiocarcinoma (Icc) and Cholangiocarcinoma, run by Cogent Biosciences, Inc. at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult
- What is being tested?
- CGT4859
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 22 Jan 2025to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
- Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
- Have measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
- Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention.
Who cannot join
- Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
- Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
- Received more than 2 prior FGFRi therapies
- Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
Taussig Cancer Center - Cleveland Clinic
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Tennessee Oncology
Nashville, Tennessee, 37203
Stanford Cancer Institute
Palo Alto, California, 94305
Fox Chase cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations
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.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification, FGFR2 Gene Short Variants
- Being tested
- CGT4859
- Keywords
- Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Advanced Solid Tumors, Investigational Drug, Phase 1, Phase 2, FGFR2, FGFR3, FGFR2/3, First in human, FGFR 2 genetic alterations, FGFR3 genetic alterations
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGT4859Drug
CGT4859 is a selective FGFR2/3 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Escalation | Experimental | Multiple doses of CGT4859 for oral administration Receives: Drug: CGT4859 |
| Phase 2: Signal Seeking | Experimental | Oral dose of CGT4859 at the RP2D as determined in Phase 1 Receives: Drug: CGT4859 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Measured: Approximately 12 months
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results
Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters
Measured: Approximately 12 months
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results
Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters
Measured: Approximately 12 months
Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Measured: Approximately 8 months
Secondary outcomes (6)
Phase 1: Pharmacokinetics
Plasma concentration levels of CGT4859
Measured: Approximately 28 days
Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Measured: Approximately 8 months
Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR)
Measured: Approximately 8 months
Phase 2: Characterize the safety of CGT4859 - AEs
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Measured: Approximately 9 months
Phase 2: Characterize the safety of CGT4859 - Labs, ECG
Changes from baseline in key laboratory results and electrocardiogram (ECG) parameters
Measured: Approximately 9 months
Phase 2: Pharmacokinetics at RP2D
Plasma concentration levels of CGT4859
Measured: Approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start22 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 will evaluate multiple ascending doses until the highest safe dose and the recommended phase 2 dose (RP2D) are determined. Phase 2 will evaluate the RP2D in 4 cohorts defined by tumor type and prior therapy based on Phase 1 results.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777316
- Sponsor's protocol ID
- CGT4859-24-101
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations
- ClinicalTrials.gov ID
- NCT06777316
- Acronym / sponsor ID
- CGT4859-24-101
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification, FGFR2 Gene Short Variants
- Keywords
- Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Advanced Solid Tumors, Investigational Drug, Phase 1, Phase 2, FGFR2, FGFR3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 will evaluate multiple ascending doses until the highest safe dose and the recommended phase 2 dose (RP2D) are determined. Phase 2 will evaluate the RP2D in 4 cohorts defined by tumor type and prior therapy based on Phase 1 results.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Escalation | Experimental | Drug: CGT4859Multiple doses of CGT4859 for oral administration |
| Phase 2: Signal Seeking | Experimental | Drug: CGT4859Oral dose of CGT4859 at the RP2D as determined in Phase 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
- Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
- Have measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
Key exclusion criteria (5 listed)
- Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
- Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
- Received more than 2 prior FGFRi therapies
- Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGT4859CGT4859 is a selective FGFR2/3 inhibitor | Drug | Phase 1: Dose Escalation, Phase 2: Signal Seeking |
Primary outcome
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Approximately 8 months
6 secondary outcomes
Phase 1: Pharmacokinetics
Time frame: Approximately 28 days
Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
Time frame: Approximately 8 months
Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR)
Time frame: Approximately 8 months
Phase 2: Characterize the safety of CGT4859 - AEs
Time frame: Approximately 9 months
Phase 2: Characterize the safety of CGT4859 - Labs, ECG
Time frame: Approximately 9 months
Phase 2: Pharmacokinetics at RP2D
Time frame: Approximately 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CGT4859 in people with Intrahepatic Cholangiocarcinoma (Icc) and Cholangiocarcinoma, run by Cogent Biosciences, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs (time frame: Approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.