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New treatment option for Malignant Neoplasms
Official title A Study of DEG6498 in Participants With Solid Tumors
ClinicalTrials.gov ID: NCT07244835
What this study is testing
What is DEG6498?
DEG6498 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for malignant neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this first in human, Phase 1, multi-center, open-label, and 2-part study is to learn whether DEG6498 is safe and tolerable in participants with advanced solid tumors. It will also learn about DEG6498 pharmacokinetics (PK) profile and potential antitumor activity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures
- Male and female older than or equal to 18 years of age at the time signing the informed consent form (ICF)
- If female, must be postmenopausal, or surgically sterile, or agree to highly effective contraceptive measures to prevent pregnancy throughout...
- Women of childbearing potential (WOCBP) must have 2 negative pregnancy tests (1 serum test required) as verified by the investigator prior to...
- If male, must agree to inform and ensure their female partners to use highly effective contraception measures to prevent pregnancy, and to refrain...
You likely can't join if
- Participant has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating...
- Participant has a condition that confounds the ability for interpret data from the study
- Pregnant or breastfeeding women
- Active or concurrent malignancy requiring treatment (including both systemic therapy and radiotherapy) within 14 days or 5 half lives (whichever is...
- Symptomatic CNS metastases which are neurologically unstable, or CNS metastases requiring local CNS directed therapy, or increasing doses of...
- Clinically significant cardiovascular disease
See the full eligibility criteria
- Willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures
- Male and female older than or equal to 18 years of age at the time signing the informed consent form (ICF)
- 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
- 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
- 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...
- Patients with advanced solid tumors, who have failed standard therapies, or for whom no standard therapy exists
- Part 1: Advanced solid tumor patients
- Part 2: Patients with BRAF mutation positive tumors and HCC
- Presence of at least 1 measurable lesion according to RECIST v1.1 .
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 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...
- Participant has a condition that confounds the ability for interpret data from the study
- Pregnant or breastfeeding women
- 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...
- 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.
- Clinically significant cardiovascular disease
- Known active or chronic infection that requires systemic therapy within 2 weeks of first dose of study drug
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome, or active HBV or HCV infection.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.