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:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT05107193
Eligibility Criteria:
Inclusion Criteria to participate in this program:
* Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring NRG1 gene fusions characterized as follows:
* Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing)
* Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing)
* Patient must have measurable or evaluable lesions (according to RECIST 1.1).
* At least 18 years of age at the time of consent.
Exclusion Criteria:
* Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
* Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available
* Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB)
* Any patient considered ineligible by the treating physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05107193
Study Brief:
Protocol Section:
NCT05107193