New pill targets gene flaws in hard-to-treat bile duct cancer
NCT ID NCT06777316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called CGT4859 in people with bile duct cancer or other advanced solid tumors that have specific changes in the FGFR2 or FGFR3 genes. The drug is designed to block these faulty genes and slow tumor growth. About 110 adults who have already tried standard treatments will take the pill, and researchers will monitor safety, side effects, and how well it shrinks or controls the cancer.
Why investors are watching
Cogent Biosciences is testing CGT4859, a drug aimed at tumors with specific FGFR2 or FGFR3 gene changes, in a phase 1/2 trial for bile duct cancer and other advanced solid tumors. For a small company, this early-stage readout matters because it is the main test of whether the drug works and is safe, and the result will shape the company's future direction.
If it works: If the trial shows the drug shrinks tumors or controls disease with manageable side effects, Cogent could advance the drug to later-stage testing and build a stronger pipeline. A positive result may also attract partnership interest from larger drug companies.
If it fails: The trial could fail to show enough benefit or reveal safety problems, which would set the program back and hurt the company's prospects. Early-phase trials often fail, so a disappointing result is a real possibility.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 measurable disease per RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits. 6. 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. Key Exclusion Criteria: 1. Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. 3. Clinically significant corneal or retinal disorders or current evidence of retinal detachment. 4. Received more than 2 prior FGFRi therapies 5. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fox Chase cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Princess Margaret Cancer Centre - UHN
Toronto, Ontario, M5G 2C4, Canada
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Stanford Cancer Institute
Palo Alto, California, 94305, United States
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Taussig Cancer Center - Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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The Christ Hospital
Cincinnati, Ohio, 45219, United States
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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- Oral drug RVU120 put to the test against advanced solid tumors