Clinical trial · Interventional
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| FGFR2 Gene Amplification | — | UNRESOLVED | — |
| FGFR2 Gene Fusion/Rearrangement | — | UNRESOLVED | — |
| FGFR2 Gene Short Variants | — | UNRESOLVED | — |
| FGFR2 Genetic Alterations | — | UNRESOLVED | — |
| FGFR3 Gene Amplification | — | UNRESOLVED | — |
| FGFR3 Gene Fusion/Rearrangement | — | UNRESOLVED | — |
| FGFR3 Gene Short Variants | — | UNRESOLVED | — |
| FGFR3 Genetic Alterations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGT4859 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation
- description
- Multiple doses of CGT4859 for oral administration
- interventionNames
- Drug: CGT4859
- type
- EXPERIMENTAL
- label
- Phase 2: Signal Seeking
- description
- Oral dose of CGT4859 at the RP2D as determined in Phase 1
- interventionNames
- Drug: CGT4859
Primary outcomes (4)
- measure
- Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
- timeFrame
- Approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available