Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07359820
Eligibility Criteria:
Inclusion Criteria:
* Unresectable, locally advanced, or metastatic solid tumor (other than CCA).
* Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.
* Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.
* Previously (\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.
* Subject has not received prior treatment with an FGFRi.
Exclusion Criteria:
* An uncontrolled comorbidity.
* Patient does not have adequate organ function (defined in protocol).
* Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
* QT interval corrected using Fridericia's formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.
* Clinically significant, uncontrolled cardiovascular disease.
* CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07359820
Study Brief:
Protocol Section:
NCT07359820