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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT07252661
Eligibility Criteria:
Inclusion Criteria (highlights):
Adults (≥ 18 years) with histologically confirmed advanced or metastatic solid tumors that have progressed after standard therapy or for which no effective standard option exists.
At least one measurable lesion per RECIST v1.1.
ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1 (2 may be allowed with Medical Monitor approval).
Resolved acute effects from prior therapy to ≤ Grade 1 per CTCAE v5.0.
Adequate organ function (hematologic, hepatic, renal).
Able to swallow oral medication and comply with study requirements.
Signed informed consent.
Women of childbearing potential must have a negative pregnancy test and use highly effective contraception during and for 180 days after treatment; men must use condoms and avoid sperm donation for 120 days post-treatment.
Exclusion Criteria (highlights):
Known primary CNS (central nervous system) malignancy or symptomatic brain metastases requiring supraphysiologic steroids (unless stable ≥ 3 months after therapy).
Active or uncontrolled infection (including HBV, HCV, HIV) not meeting protocol control criteria.
HBV: Hepatitis B Virus HCV: Hepatitis C Virus HIV: Human Immunodeficiency Virus
Significant GI disease that could impair oral drug absorption (e.g., unresolved Grade \> 1 nausea/diarrhea).
Active liver or biliary disease (except stable metastases or Gilbert's syndrome).
Baseline QTcF (QT Interval Corrected Using Fridericia Formula) \> 450 msec (men) or \> 470 msec (women), clinically significant ECG abnormalities, or heart rate \< 45 bpm unless approved by cardiology review.
Pregnant or breastfeeding women.
Any other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07252661
Study Brief:
Protocol Section:
NCT07252661