A Study of DEG6498 in Participants With Solid Tumors
ConditionMalignant Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDegron Therapeutics Co.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
DEG6498
DrugDEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: DEG6498 TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT)
Number of participants with DLT in Part 1
Time frame
From first dose through the end of Cycle 1 (each cycle is 28 days)2
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
Time frame
From Screening up to 30 days after the last doseSecondary outcomes
1
Area under the concentration-time curve (AUC) of DEG6498
Measurement of plasma concentration over time for exposure to 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)2
Maximum concentration (Cmax) of DEG6498
Measurement of plasma concentration over time for exposure to 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)3
Time to reach maximum concentration (Tmax),
Measurement of plasma concentration over time for DEG6498 to reach maximum concentration
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)4
Terminal half-life (T1/2) of DEG6498
Measurement of the clearance of DEG6498 from plasma over time
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)Sponsors and contacts
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Source ClinicalTrials.gov