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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT04618393
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent.
* Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
* Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. \> 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
* Archival tumor samples available for retrospective analysis or biopsy will be taken.
* ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy \> 3 Months
* Adequate organ function to participate in the trial.
* Recovery from adverse events (AEs) related to prior anticancer therapy.
* Highly effective contraception
Exclusion Criteria:
* Patients who have active autoimmune disease or history of autoimmune disease
* History of severe irAE.
* History of severe allergic reactions
* Use of systemic corticosteroids.
* Symptomatic central nervous system metastases.
* Patients with cardiac dysfunction
* Uncontrolled diabetes mellitus with hemoglobin A1c \> 8% (via medical history)
* Prior treatment with a LAG-3 inhibitor
* Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
* Prior organ or stem cell/bone marrow transplant.
* Concurrent malignancy \< 5 years prior to entry.
* Patients with active infections.
* Major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment
* Live virus vaccines \< 30 days prior to screening
* Pregnant or breast-feeding females
* Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
* Any other serious underlying medical conditions
* Abuse on alcohol, cannabis- derived products or other drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04618393
Study Brief:
Protocol Section:
NCT04618393