Actively Recruiting
A Phase I/IIa Trial of AD1208, a Cell Cycle Inhibitor/MASTL Inhibitor, as a Single Agent or Combination in Adults With Progressive, Locally Advanced or Metastatic Solid Tumors
Led by Avelos Therapeutics Inc. · Updated on 2025-04-04
36
Participants Needed
3
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of AD1208, a cell cycle inhibitor/MASTL inhibitor, in adults with any progressive, locally advanced (unresectable) or metastatic solid tumors. This phase I/IIa trial aims to find the maximum tolerated dose or maximum administered dose of AD1208 and to understand the medical issues participants may experience while taking this drug. The study addresses important questions about which dosage is safe and how participants tolerate the treatment. AD1208 is given orally once or twice daily in 21-day treatment cycles. The trial includes a dose-escalation phase divided into phase 1a for monotherapy dose recommendation and phase 1b for combination therapy dose recommendation. Participants may receive one of several doses ranging from 40 mg twice daily up to 340 mg twice daily. During the first cycle, participants visit the study site weekly for checkups and tests, then every three weeks from the second cycle onward. Participants will also keep a diary to record any adverse events and drug administration. Participants will be involved in regular assessments including laboratory tests to check blood, liver, and kidney function before and during treatment. Researchers will monitor safety and tolerability at the end of the first 21-day cycle. Additional measures include drug concentrations in the blood at specific times during cycle 1 and ongoing evaluations of tumor response and disease progression for approximately one year. The study includes careful monitoring of treatment duration, disease control, and survival outcomes until study completion.
CONDITIONS
Brief Title
AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 19 years of age or older
- Willing to consent and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures
- Histologically or cytologically confirmed progressive, locally advanced (unresectable), or metastatic solid tumors that are relapsed or refractory after last treatment
- ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood, liver, and kidney function based on screening tests within 2 weeks before first study drug dose
- Female subjects who are surgically sterile, postmenopausal, or agree to use highly effective birth control during the study and for 6 months after last dose
- Male subjects with pregnant or breastfeeding partners must agree to abstain or use condoms during the study and for 6 months after last dose
You will not qualify if you...
- Untreated active brain metastases
- Presence of leptomeningeal disease
- Unresolved adverse events greater than Grade 1 from prior therapy except alopecia
- Active autoimmune disease requiring systemic treatment within past 2 years
- Active interstitial lung disease, pneumonitis, or history of ILD
- Prior anticancer monoclonal antibody treatment, investigational therapy, chemotherapy, radiotherapy, or major surgery
- Clinically significant active cardiovascular disease
- Known HIV infection
- Active hepatitis B or C infection
- Known allergy to active or inactive ingredients of the study drug
- Recent live vaccine against infectious disease
- Gastrointestinal disease preventing oral medication intake, malabsorption, or uncontrolled inflammatory GI disease
- Psychiatric illness or social situations limiting study compliance
- Positive pregnancy test at screening or breastfeeding
- Any condition deemed by investigator to make participation unsafe or unsuitable
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive AD1208 orally once or twice daily in 21-day cycles. Treatment continues through multiple cycles until disease progression or discontinuation.
Visits at Day 1 and Day 15 of each 21-day cycle
Trial Site Locations
Total: 3 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
S
Soongyu Choi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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