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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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. \[For South Korea only: Relapsed from, refractory to, or intolerant to all available therapies (eg, SOC therapy domestically approved) for their condition.\]
✓. HLA-A\*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive.
✓. 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.

✕. Has received prior therapy targeting NY-ESO-1.
✕. Has an inadequate treatment washout period prior to the start of trial intervention, defined as follows:
✕. Radiation therapy: \<4 weeks (or \<2 weeks if palliative radiation therapy without abdominal/pelvic radiation)
✕. Chemotherapy, antibody-based anticancer therapy, immunotherapy: \<4 weeks
✕. 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

Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a

Timeframe: Up to 18 months

Part 2: Number of participants with Treatment-Emergent Adverse Events

Timeframe: Up to 3 years

Part 2: Objective Response Rate

Timeframe: From day of first dose up to 3 years

NCT IDNCT06644755

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-11-30

Contact for Trial Information

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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. \[For South Korea only: Relapsed from, refractory to, or intolerant to all available therapies (eg, SOC therapy domestically approved) for their condition.\]
✓. HLA-A\*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive.
✓. 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.

✕. Has received prior therapy targeting NY-ESO-1.
✕. Has an inadequate treatment washout period prior to the start of trial intervention, defined as follows:
✕. Radiation therapy: \<4 weeks (or \<2 weeks if palliative radiation therapy without abdominal/pelvic radiation)
✕. Chemotherapy, antibody-based anticancer therapy, immunotherapy: \<4 weeks
✕. 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