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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04281420
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained prior to any screening procedures and in accordance with local and institutional guidelines.
2. Age ≥18 years.
3. Patients with histologically or cytologically confirmed, NHL or advanced solid tumors which have progressed despite standard therapy, for whom no standard therapy exists, or who have refused standard therapy.
4. Patients must have objective evidence of PD on study entry:
1. Advanced solid tumors: Measureable disease as defined by RECIST 1.11.
2. NHL: Measureable disease including target lesion(s) as defined by the Cheson 2014 Classification2 for initial evaluation and staging.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
6. Adequate hepatic function.
7. Adequate renal function.
8. Life expectancy of ≥ 3 months.
9. Adequate hematopoietic function.
10. Female patients of child-bearing potential must agree to use dual methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at Screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.
Exclusion Criteria:
1. Female patients who are pregnant or lactating.
2. Time since the last prior therapy for treatment of advanced solid tumors or NHL\*\*:
1. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anti-cancer therapy ≤ 4 weeks prior to C1D1.
2. Palliative steroids for disease related symptoms within 7 days prior to C1D1.
3. Known central nervous system metastases.
4. Major surgery within 4 weeks before C1D1.
5. Impaired cardiac function or clinically significant cardiac diseases.
6. Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within 1 week prior to C1D1.
7. Patients diagnosed with tuberculosis and had received treatment.
8. Patients with a known history of human immunodeficiency virus (HIV).
9. Known, active hepatitis A, B, or C infection.
10. Serious psychiatric or medical conditions that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04281420
Study Brief:
Protocol Section:
NCT04281420