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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT04349969
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide written and signed informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
3. Life expectancy ≥12 weeks
4. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product or women of non-childbearing potential.
5. Willing to receive blood transfusion(s) when so advised by the investigator.
6. Adequate organ function.
7. Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
8. At least 1 measurable lesion according to RECIST v1.1
Exclusion Criteria:
1. Concurrent enrollment in another clinical study excluding observational trials
2. Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
3. Active brain/central nervous system (CNS) metastases
4. Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
5. Known history of HIV.
6. Known active hepatitis B or C infections
7. Active or prior documented autoimmune disease that may relapse.
8. History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
9. History of defects in RBC production, or hemoglobin production or metabolism
10. Patients with clinically significant cardio-cerebrovascular disease.
11. History of severe hypersensitivity reactions to other mAbs.
12. History of organ transplantation.
13. Receiving any anticancer therapy targeting the CD47/SIRPα ; Anticancer small molecule targeted agent within 2 weeks prior to the first dose of the investigational product; Anticancer mAbs within 6 weeks prior to the first dose of investigational product or 5 half-lives (whichever is lesser); Other anticancer therapy within 4 weeks prior to the first dose of the investigational product;
14. Subjects with a condition requiring systemic treatment with either corticosteroid (\>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to the first dose of investigational product.
15. Received a live attenuated vaccine within 4 weeks prior to the first dose of investigational product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04349969
Study Brief:
Protocol Section:
NCT04349969