DEG6498 for people with advanced solid tumors

A First in Human Phase 1 Open-Label, Multicenter, Dose Escalation and Expansion Study of DEG6498 in Patients With Solid Tumors

This Phase 1 study will try once-daily oral DEG6498 in adults with advanced solid tumors, including BRAF-mutant cancers and liver cancer, who have no standard treatment to see if it is safe and shows signs of anti-tumor activity.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Degron Therapeutics Co. (industry)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07244835 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, multi-center, open-label Phase 1 trial with two parts: a dose-escalation phase to determine the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase focusing on BRAF-mutant tumors and hepatocellular carcinoma (HCC). Participants will take DEG6498 orally once a day and undergo regular safety monitoring, blood sampling for pharmacokinetics (PK), and tumor assessments. The study will record adverse events, dose-limiting toxicities, and any tumor responses to characterize safety and preliminary efficacy. Data from both parts will guide dose selection and further clinical development.

Who should consider this trial

Good fit: Adults aged 18 or older with advanced solid tumors who have exhausted standard therapies or have no available standard treatment, and who meet the study's safety and contraception requirements, are the intended candidates.

Not a fit: Patients with early-stage or readily treatable cancers, those who can receive effective standard therapies, pregnant or breastfeeding individuals, or those unable to take oral medication are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, DEG6498 could become a new oral treatment option that controls tumor growth for patients with BRAF-mutant cancers or hepatocellular carcinoma who lack effective standard therapies.

How similar studies have performed: Other targeted oral agents have shown benefit in some BRAF-mutant tumors and select liver cancers, but DEG6498 is a first-in-human agent and its safety and efficacy are not yet proven.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Degron Therapeutics Co.

Conditions: Malignant Neoplasms, DEG6498, Solid tumor, Phase 1, BRAF mutation, Hepatocellular carcinoma, Melanoma, Colorectal cancer