NCT07244835

A Study of DEG6498 in Participants With Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Degron Therapeutics Co. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be conducted in 2 Parts. Part 1, the dose escalation part of the study, will test different doses of DEG6498 as a single agent when administered to participants with any type of advanced solid tumor that has no available alternative treatments, and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) for further studies. Part 2, the dose expansion part of the study, will further characterize the safety/tolerability profile and clinical activities of DEG6498 in 2 tumor types: BRAF mutant tumors and hepatocellular carcinoma (HCC).

Conditions

• Malignant Neoplasms

Interventions

Type	Name	Description
DRUG	DEG6498	DEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR).

Timeline

• Start date: 2025-11-13
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-11-24
• Last updated: 2025-12-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study