Evaluating CGT4859 for Cholangiocarcinoma and Advanced Solid Tumors

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 study is testing a new drug called CGT4859 to see if it can help adults with advanced bile duct cancer or other solid tumors that have certain genetic changes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cogent Biosciences, Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Palo Alto, California and 9 other locations)
• Trial ID: NCT06777316 on ClinicalTrials.gov

What this trial studies

This study is an open-label, phase 1/2 evaluation of CGT4859, an FGFR2/3 inhibitor, in adult patients with intrahepatic cholangiocarcinoma or other advanced solid tumors that have specific genetic alterations. The trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of the drug. Participants must have measurable disease and have either been previously treated or are not suitable for standard first-line therapies. The study will monitor the effects of CGT4859 on tumor progression and patient health.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced, unresectable intrahepatic cholangiocarcinoma or other solid tumors who have documented FGFR2/3 genetic alterations.

Not a fit: Patients who have not been previously treated or are suitable for standard first-line therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cholangiocarcinoma and other solid tumors with FGFR2/3 alterations.

How similar studies have performed: Other studies targeting FGFR alterations in solid tumors have shown promise, indicating that this approach may be beneficial.

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.

Where this trial is running

Palo Alto, California and 9 other locations

• Stanford Cancer Institute — Palo Alto, California, United States (RECRUITING)
• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• Taussig Cancer Center - Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• Fox Chase cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
• Tennessee Oncology — Nashville, Tennessee, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Huntsman Cancer Institute - University of Utah — Salt Lake City, Utah, United States (RECRUITING)
• Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Study coordinator: Cogent Biosciences, Inc.

Conditions: Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Amplification, FGFR2 Gene Short Variants, FGFR3 Gene Fusion/Rearrangement, FGFR3 Gene Amplification