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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT07244835
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures
2. Male and female older than or equal to 18 years of age at the time signing the informed consent form (ICF)
3. If female, must be postmenopausal, or surgically sterile, or agree to highly effective contraceptive measures to prevent pregnancy throughout treatment period and within 30 days of last study drug treatment
4. Women of childbearing potential (WOCBP) must have 2 negative pregnancy tests (1 serum test required) as verified by the investigator prior to starting study drug
5. If male, must agree to inform and ensure their female partners to use highly effective contraception measures to prevent pregnancy, and to refrain from donating sperm while on study drug and for at least 30 days following DEG6498 discontinuation
6. Patients with advanced solid tumors, who have failed standard therapies, or for whom no standard therapy exists
1. Part 1: Advanced solid tumor patients
2. Part 2: Patients with BRAF mutation positive tumors and HCC
7. Presence of at least 1 measurable lesion according to RECIST v1.1 .
8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
1. Participant has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study, puts the participant at unacceptable risk if he/she were to participate in the study
2. Participant has a condition that confounds the ability for interpret data from the study
3. Pregnant or breastfeeding women
4. Active or concurrent malignancy requiring treatment (including both systemic therapy and radiotherapy) within 14 days or 5 half lives (whichever is shorter) prior to the first dose of study drug, or received antibody therapy within 28 days
5. Symptomatic CNS metastases which are neurologically unstable, or CNS metastases requiring local CNS directed therapy, or increasing doses of corticosteroids within 2 weeks of first dose of study treatment.
6. Clinically significant cardiovascular disease
7. Known active or chronic infection that requires systemic therapy within 2 weeks of first dose of study drug
8. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome, or active HBV or HCV infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07244835
Study Brief:
Protocol Section:
NCT07244835