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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05021120
Eligibility Criteria:
Inclusion Criteria:
1. Written and signed informed consent
2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies
3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy
4. Subject must have at least one measurable lesion according to RECIST Version1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
6. Available archived or fresh tumor tissue
7. Adequate organ function.
8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
9. 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.
Exclusion Criteria:
1. History of severe hypersensitivity reactions to other mAbs.
2. Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
5. Any major surgery within 4 weeks prior to the first dose of treatment
6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
7. Active or prior documented inflammatory bowel disease
8. History of organ transplant.
9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
10. Known active hepatitis B or C infections or history of HIV.
11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
12. Patients with severe heart and lung dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05021120
Study Brief:
Protocol Section:
NCT05021120