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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT03314935
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
* Presence of measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
* Resolution of treatment-related toxicities.
* Adequate hepatic, renal, cardiac, and hematologic function.
* Additional cohort-specific criteria may apply.
Exclusion Criteria:
* Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
* Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
* Has received prior approved radiotherapy within 14 days of study therapy.
* Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03314935
Study Brief:
Protocol Section:
NCT03314935