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New treatment option for Solid Tumor, Adult
Official title AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06911333
What this study is testing
What is AD1208?
AD1208 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Male or female people ≥19 years of age
- Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
You likely can't join if
- Untreated active brain metastases.
- has leptomeningeal disease.
- unrecovered \> Grade 1 from the adverse event of prior therapy except for alopecia.
- has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.
- Subject has received the following treatment;
See the full eligibility criteria
- Male or female people ≥19 years of age
- Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- people with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.
- Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for...
- Untreated active brain metastases.
- has leptomeningeal disease.
- unrecovered \> Grade 1 from the adverse event of prior therapy except for alopecia.
- has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.
- Subject has received the following treatment;
- prior anticancer monoclonal antibody treatment or investigational therapy
- prior any chemotherapy
- prior radiotherapy
- Major surgery
- Clinically significant (i.e., active) cardiovascular disease
- known positive of human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C people.
- known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.
- Live vaccine administered against infectious disease.
- Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.
- having psychiatric illness/social situations that would limit compliance with study requirements.
- women with a positive pregnancy test at screening test.
- women who are breast feeding.
- subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.