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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04843033
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 75 years inclusive;
2. Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
4. Life expectancy ≥ 3 months;
5. Adequate hematologic, hepatic and renal function;
6. Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;
7. Provision of signed and dated, written informed consent prior to any study-specific evaluation.
Exclusion Criteria:
1. Previous treatment with any SHP2 inhibitors;
2. Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;
3. Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
4. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
5. Patients who have impaired cardiac function or clinically significant cardiac diseases;
6. Active, clinically significant interstitial lung disease or pneumonitis;
7. Females who are pregnant or breastfeeding;
8. Judgment by the investigator that the patient should not participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04843033
Study Brief:
Protocol Section:
NCT04843033