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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (13)
Facility
City
Region
Status
Stanford Cancer Institute
Palo Alto
California
Mayo Clinic Jacksonville
Jacksonville
Florida
Moffitt Cancer Center
Tampa
Florida
University of Chicago Medicine Comprehensive Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.