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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT04303858
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced/unresectable or metastatic disease
* No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group Performance Status 0 to 1
* Life expectancy of \>=12 weeks
* Consent to provide an archival tumor tissue sample
* Adequate cardiovascular, hematological, coagulative, hepatic and renal function
Exclusion Criteria:
* Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
* Untreated central nervous system (CNS) metastases
* Treated asymptomatic CNS metastases
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>= 2 weeks before Cycle1 Day 1 (C1D1)
* Active or history of carcinomatous meningitis/leptomeningeal disease
* Uncontrolled tumor-related pain or symptomatic hypercalcemia
* Concurrent second malignancy
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
* Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration
* Active or uncontrolled infections
* Known HIV infection
* Hepatitis B virus (HBV) or hepatitis C virus infection
* Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade \<=1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy
* Participants with bilateral pleural effusion
* Major surgery or significant traumatic injury \< 28 days before study treatment administration or anticipation of the need for major surgery during study treatment
* Known allergy or hypersensitivity to any component of the formulations of the IMPs to be administered, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanized antibodies
* History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
* Previous treatment with Interleukin-2 (IL-2)/Interleukin-5 (IL-15)-like cytokines. IL-2/IL-15 use as an adjunct treatment component for adoptive cell therapy is permitted. In Part 3, patients who have received adoptive cell therapy such as tumor-infiltrating lymphocytes (TIL) are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04303858
Study Brief:
Protocol Section:
NCT04303858