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Kinase Inhibitor
CGT4859 for Bile Duct Cancer
Palo Alto, CA
Phase 1 & 2
Recruiting
Research Sponsored by Cogent Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor
Must not have
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
Received more than 2 prior FGFRi therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, CGT4859, in adults with a specific type of liver cancer or other advanced solid tumors. The study will look at how safe and tolerable the drug
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Who is the study for?
This trial is for adults with intrahepatic cholangiocarcinoma (a type of liver bile duct cancer) or other advanced solid tumors that have specific genetic changes in FGFR2 and/or FGFR3. Participants should meet certain health standards to be included.Check my eligibility
What is being tested?
The study is testing CGT4859, a drug aimed at targeting cancers with certain genetic alterations. It's an early-phase trial to assess how safe it is, how the body processes it, and its effectiveness against these cancers.See study design
What are the potential side effects?
As this is an early-phase trial for CGT4859, detailed side effects are being studied; however, common side effects may include nausea, fatigue, diarrhea and potential risks associated with drugs affecting cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is advanced and cannot be removed by surgery, with confirmed FGFR2/3 changes.
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I have either tried, am not eligible for, or have refused standard first-line treatment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had major surgery in the last 4 weeks.
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I have had more than 2 treatments targeting FGFR.
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I do not have major eye problems like corneal or retinal disorders.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results
Secondary study objectives
Phase 1: Pharmacokinetics
Phase 2: Characterize the safety of CGT4859 - AEs
Phase 2: Characterize the safety of CGT4859 - Labs, ECG
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Signal SeekingExperimental Treatment1 Intervention
Oral dose of CGT4859 at the RP2D as determined in Phase 1
Group II: Phase 1: Dose EscalationExperimental Treatment1 Intervention
Multiple doses of CGT4859 for oral administration
Find a Location
Closest Location:Tennessee Oncology· Nashville, TN· 334 miles
Who is running the clinical trial?
Cogent Biosciences, Inc.Lead Sponsor
10 Previous Clinical Trials
983 Total Patients Enrolled