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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT07055594
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects aged ≥ 18 years old.
2. Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists:
1. Non-small cell lung cancer (NSCLC);
2. Ovarian cancer (OC);
3. Head and neck carcinoma (H\&N);
4. Breast cancer (BC);
5. Colorectal cancer (CRC).
3. Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.
4. At least one measurable lesion
5. Adequate organ function
6. Female subject must either not be of childbearing potential or a negative pregnancy test
7. Non-vasectomized male subjects must practice highly effective contraception
Exclusion Criteria:
1. Active bacterial, fungal, viral OR atypical infection requiring systemic medication.
2. Received any investigational drug within 4 weeks before screening.
3. Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.
4. Symptomatic, unstable central nervous system malignancy OR metastasis
5. Have received organ or tissue transplantation or allogeneic cell therapies.
6. Non-adequate cardiac function
7. Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07055594
Study Brief:
Protocol Section:
NCT07055594