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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05451602
Eligibility Criteria:
Inclusion Criteria:
* Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
* Phase 2： All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.
* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
* Measurable or non-measurable disease as determined by RECIST 1.1;
* Adequate hematologic, hepatic and renal function;
* Life expectancy of at least 12 weeks;
* Negative pregnancy test (urine or serum) for female patients of childbearing potential;
* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).
Exclusion Criteria:
* Participant's cancer has a known primary driver alteration other than RET.
* Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;
* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;
* Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);
* Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;
* Had received live vaccine within 4 weeks prior to study treatment;
* Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials;
* Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .
* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.
* Patients with other malignant tumors within 5 years before the first use of drugs
* Patients have a history of severe cardiovascular disease;
* Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10\^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive.
* Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;
* Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);
* Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;
* Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05451602
Study Brief:
Protocol Section:
NCT05451602