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NCT Number: NCT07244835

A Study of DEG6498 in Participants 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.

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Key information

Conditions

Malignant Neoplasms Adenocarcinoma Adnexal Diseases Astrocytoma Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosarcoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Glioma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibrosarcoma Neuromuscular Diseases Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 following DEG6498 discontinuation
  • 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

Exclusion criteria

  • 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
  • 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 therapy within 28 days
  • 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.

Treatment and study plan

DEG6498

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Degron Therapeutics Co.

CONTACT

[email protected]

+86-21-60799565

Sponsors and collaborators

Lead sponsor

Degron Therapeutics Co.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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