Malignant NeoplasmsPhase 1NCT07244835
A Study of DEG6498 in Participants With Solid Tumors
A Phase 1 study testing DEG6498 in people with Malignant Neoplasms, run by Degron Therapeutics Co. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms
- What is being tested?
- DEG6498
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 13 Nov 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, MD, +86 13911219511, linshenpku@163.com
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
Ming Lu, MD, +86 15801292978, minglupku@126.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Dr. Ma, MD, +86-13580385541, mayx@sysucc.org.cn
About this study
Official title: 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.
Read the 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
- Being tested
- DEG6498
- 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)
- Medical subject headings
- Neoplasms, Carcinoma, Hepatocellular, Melanoma, Colorectal Neoplasms, Lung Neoplasms, Thyroid Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEG6498Drug
DEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DEG6498 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT)
Number of participants with DLT in Part 1
Measured: 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
Measured: From Screening up to 30 days after the last dose
Secondary outcomes (9)
Area under the concentration-time curve (AUC) of DEG6498
Measurement of plasma concentration over time for exposure to DEG6498
Measured: 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
Measurement of plasma concentration over time for exposure to DEG6498
Measured: 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),
Measurement of plasma concentration over time for DEG6498 to reach maximum concentration
Measured: 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
Measurement of the clearance of DEG6498 from plasma over time
Measured: 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
Measurement of the clearance of DEG6498 from plasma over time
Measured: 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)
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
Measured: 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)
The time interval from the first DEG6498 dose date to the date of first documented objective response
Measured: 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)
The proportion of participants with a best ORR + Stable Disease (SD)
Measured: 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)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start13 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Degron Therapeutics Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244835
- Sponsor's protocol ID
- DEG6498-ONC-2401
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Phase 1 Open-Label, Multicenter, Dose Escalation and Expansion Study of DEG6498 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07244835
- Acronym / sponsor ID
- DEG6498-ONC-2401
- Conditions
- Malignant Neoplasms
- Keywords
- DEG6498, Solid tumor, Phase 1, BRAF mutation, Hepatocellular carcinoma (HCC), Melanoma, Colorectal cancer (CRC), Lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Degron Therapeutics Co.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DEG6498 Treatment | Experimental | Drug: DEG6498Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEG6498DEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR). | Drug | DEG6498 Treatment |
Primary outcome
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
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
9 secondary outcomes
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)
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)
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)
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)
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)
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DEG6498 in people with Malignant Neoplasms, run by Degron Therapeutics Co. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Degron Therapeutics Co. (+86-21-60799565, clinicaltrials@degrontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) (time frame: From first dose through the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.