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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT06065059
Eligibility Criteria:
Inclusion Criteria:
* Is ≥18 years of age at the time of signature of the main study ICF.
* Has ECOG performance status of 0 or 1.
* Has advanced or metastatic solid tumor with measurable disease based on RECIST v1.1.
* All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test
* Adequate organ and bone marrow function per local labs
* Negative serum pregnancy test result at screening
* Written informed consent must be obtained according to local guidelines
Exclusion Criteria:
* Known allergies, hypersensitivity, or intolerance to TNG348, olaparib or its excipients
* Uncontrolled intercurrent illness that will limit compliance with the study requirements
* Currently participating in or has planned participation in a study of another investigational agent or device
* Impairment of GI function or disease that may significantly alter the absorption of study drug
* Active prior or concurrent malignancy.
* Central nervous system metastases associated with progressive neurological symptoms
* Participant with MDS
* Clinically relevant cardiovascular disease
* Participant with known active or chronic infection
* A female patient who is pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06065059
Study Brief:
Protocol Section:
NCT06065059