A Study of DEG6498 in Participants With Solid Tumors

NCT07244835 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DEG6498-ONC-2401
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasms

Keywords

DEG6498; Solid tumor; Phase 1; BRAF mutation; Hepatocellular carcinoma (HCC); Melanoma; Colorectal cancer (CRC); Lung cancer; Thyroid cancer; Ovarian cancer; Pancreatic cancer; Glioblastoma; Renal cancer; Malignant peripheral nerve sheath tumor (MPNST)

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLT)

  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

  Number, type, frequency, severity, timing, and relationship to DEG6498 of AEs, SAEs, etc

  From Screening up to 30 days after the last dose

Secondary Outcomes (9)

• Area under the concentration-time curve (AUC) of 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

  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),

  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

  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

  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)

Study Arms (1)

DEG6498 Treatment

EXPERIMENTAL

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

Interventions

DEG6498 DRUG

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

DEG6498 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Degron Therapeutics Co.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoma, Hepatocellular; Melanoma; Colorectal Neoplasms; Lung Neoplasms; Thyroid Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Glioblastoma; Kidney Neoplasms; Neurofibrosarcoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Degron Therapeutics Co.

CONTACT

+86-21-60799565; clinicaltrials@degrontx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a dose escalation and dose expansion Ph1 study. In dose escalation part, participants in single arms will receive DEG6498 capsules daily from a starting dose with dose escalation decision made at a 3+3 model.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 24, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)