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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07317505
Eligibility Criteria:
Major Inclusion Criteria:
* Age ≥18 years
* Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available
* At least one evaluable tumor lesion according to RECIST v1.1.
* ECOG performance status score ≤2.
* Expected survival ≥ 3 months
Major Exclusion Criteria:
* Active central nervous system metastases and/or leptomeningeal metastases
* AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0
Prior therapy
* Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
* Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:
1. Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
2. Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug;
3. Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07317505
Study Brief:
Protocol Section:
NCT07317505