Actively Recruiting
AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors
Led by Avelos Therapeutics Inc. · Updated on 2025-04-04
36
Participants Needed
3
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are: * Which dosage of AD1208 is safe and tolerable for participants? * What medical problems do participants have when taking AD1208? Participants will: * Take drug AD1208 every day up to 1 cycle at the least. * Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards. * Keep a diary of any adverse events and administrated drug
CONDITIONS
Official 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 study visits, treatment plan, laboratory tests, and procedures
- Histologically or cytologically confirmed progressive, locally advanced (unresectable), or metastatic solid tumors that relapsed or are refractory after last treatment
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood, liver, and kidney function based on screening tests within 2 weeks before starting treatment
- Female subjects who are surgically sterile, postmenopausal, or agree to use two highly effective birth control methods during the study and for 6 months after the last dose
- Male subjects with pregnant or breastfeeding partners agree to abstain or use condoms during the study and for 6 months after the last dose
You will not qualify if you...
- Untreated active brain metastases
- Presence of leptomeningeal disease
- Not recovered beyond Grade 1 from prior therapy adverse events except for hair loss
- Active autoimmune disease requiring systemic treatment within past 2 years
- Active interstitial lung disease, pneumonitis, or history of these conditions
- Prior treatment with anticancer monoclonal antibodies, chemotherapy, radiotherapy, or major surgery
- Active cardiovascular disease
- Known positive HIV infection
- Active hepatitis B or C infection
- Known allergic reaction to investigational product ingredients
- Recent live vaccine against infectious disease
- Gastrointestinal disease preventing oral medication intake or causing malabsorption
- Psychiatric illness or social situations limiting study compliance
- Positive pregnancy test at screening
- Currently breastfeeding
- Any condition that would make participation not in the subject's best interest according to the investigator
AI-Screening
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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
CONTACT
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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