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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT05487235
Eligibility Criteria:
Inclusion Criteria:
* Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
* Has Life expectancy \>= 12 weeks
* Adequate organ function
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Inclusion Criteria for Dose-Finding Stage:
* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable
Inclusion Criteria for Expansion Stage: NSCLC Cohort
* Histologically confirmed locally advanced or metastatic NSCLC
* Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
* PD- L1 positive
* No prior systemic therapy for locally advanced or metastatic NSCLC
Inclusion Criteria for Expansion Stage: HNSCC Cohort
* Histologically confirmed recurrent, or metastatic HNSCC
* PD-L1 positive
* No prior systemic therapy for recurrent or metastatic HNSCC
Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort
* Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy
Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort
* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
* Has leptomeningeal disease or carcinomatous meningitis
* Has uncontrolled hypertension
* Has left ventricular ejection fraction \< institutional lower limit of normal or \< 50%
* Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05487235
Study Brief:
Protocol Section:
NCT05487235