A Study of DEG6498 in Participants With Solid Tumors

May 11, 2026 updated by: Degron Therapeutics Co.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEG6498 Treatment

Participants in dose escalation part will receive DEG6498 capsules orally once a day in each treatment cycle of 28 days at different ascending dose level.

Participants in dose expansion part will receive DEG6498 capsules orally once a day in each treatment cycle of 28 days at a dose level decided based on dose escalation results.
Drug: DEG6498
DEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicity (DLT)
Time Frame: From first dose through the end of Cycle 1 (each cycle is 28 days)
Number of participants with DLT in Part 1
From first dose through the end of Cycle 1 (each cycle is 28 days)
Incidence of adverse events (AEs) and serious AEs (SAEs) as assessed by CTCAE v5.0
Time Frame: From Screening up to 30 days after the last dose
Number, type, frequency, severity, timing, and relationship to DEG6498 of AEs, SAEs, etc
From Screening up to 30 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve (AUC) of DEG6498
Time Frame: From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Measurement of plasma concentration over time for exposure to DEG6498
From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Maximum concentration (Cmax) of DEG6498
Time Frame: From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Measurement of plasma concentration over time for exposure to DEG6498
From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Time to reach maximum concentration (Tmax),
Time Frame: From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Measurement of plasma concentration over time for DEG6498 to reach maximum concentration
From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Terminal half-life (T1/2) of DEG6498
Time Frame: From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Measurement of the clearance of DEG6498 from plasma over time
From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Clearance following oral dose (CL/F) of DEG6498
Time Frame: From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Measurement of the clearance of DEG6498 from plasma over time
From Day 1 in Cycle 1 followed by Day 1 of each treatment cycle through treatment until EOT visit, expected average 6 months (each cycle is 28 days)
Overall response rate (ORR)
Time Frame: From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
The proportion of participants with best overall response of complete response (CR) or partial response (PR) as determined by the Investigator per RECIST 1.1
From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
Time to response (TTR)
Time Frame: From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
The time interval from the first DEG6498 dose date to the date of first documented objective response
From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
Disease control rate (DCR)
Time Frame: From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
The proportion of participants with a best ORR + Stable Disease (SD)
From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
Duration of response (DOR)
Time Frame: From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months
The time interval from the earliest occurrence of a documented objective response to the first time of disease progression or death from any cause, whichever comes first
From the date of dosing until the date of first documented progression, unacceptable toxicity, death from any cause, participant withdraw consent, or investigator's decision, whichever occurs first, expected up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Degron Therapeutics Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEG6498-ONC-2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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