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

Launched by COGENT BIOSCIENCES, INC. · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CGT4859 to see how safe it is and how well it works for patients with advanced solid tumors, particularly a type of liver cancer known as intrahepatic cholangiocarcinoma (iCCA). The trial is open to adults who have specific genetic changes in their tumors related to the FGFR2 or FGFR3 genes. To participate, patients need to have a confirmed diagnosis of locally advanced or metastatic iCCA or other solid tumors, and they should have already tried or not be suitable for standard treatment options.

Participants in the trial will receive the study medication and will be monitored closely for any side effects and how the drug affects their tumors. The trial is currently looking for patients who are generally healthy enough to take part, meaning they should have a good performance status and meet certain health requirements. This is an important study that aims to find new treatment options for patients with limited choices, and it may provide valuable information for future therapies.

Gender

ALL

Eligibility criteria

• 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.