NCT07244835 A Study of DEG6498 in Participants With Solid Tumors
| NCT ID | NCT07244835 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Degron Therapeutics Co. |
| Condition | Malignant Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-11-13 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The main questions it aims to answer are: * what is an appropriate dose to be given to participants? * are the side effects of treatment manageable? Participants who are treated in this study will receive DEG6498 orally once a day and be closely monitored by the treating physicians.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07244835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07244835 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07244835 currently recruiting?
Yes, NCT07244835 is actively recruiting participants. Contact the research team at clinicaltrials@degrontx.com for enrollment information.
Where is the NCT07244835 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China.
Who is sponsoring the NCT07244835 clinical trial?
NCT07244835 is sponsored by Degron Therapeutics Co.. The trial plans to enroll 100 participants.