First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors (NCT06644755) | Clinical Trial Compass
RecruitingPhase 1
First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
United States, Belgium, France150 participantsStarted 2024-11-14
Plain-language summary
This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Sign and date the main ICF.
. Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first.
. One of the following histologically or cytologically documented cancers:
. Relapsed from, refractory to, or intolerant to appropriate therapies \[eg, standard of care (SOC) therapy\] to provide clinical benefit for their condition as assessed by their physician and/or investigator. \[For South Korea only: Relapsed from, refractory to, or intolerant to all available therapies (eg, SOC therapy domestically approved) for their condition.\]
. Has measurable disease based on RECIST v1.1 on computed tomography/magnetic resonance imaging (CT/MRI).
. Is willing and able to provide adequate pre-treatment or archival tumor tissue sample.
. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at Screening.
Exclusion criteria
. Has received prior therapy targeting NY-ESO-1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a
Timeframe: Up to 18 months
2
Part 2: Number of participants with Treatment-Emergent Adverse Events
. Small molecules (eg, tyrosine kinase inhibitors): \<2 weeks or 5 half-lives, whichever is longer
. Has known symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable.
. Uncontrolled or clinically significant cardiovascular disease, including the following:
. Myocardial infarction within 6 months prior to screening