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First-in-Human Trial of DS-2243a for Advanced Solid Tumors

This study is testing a new drug called DS-2243a for people with advanced solid tumors, including sarcoma. It's a "first-in-human" trial, meaning it's one of the first times this drug is being given to people. The main goals are to see how safe DS-2243a is, what side effects it might cause, and if it can shrink tumors. You might be able to join if you are an adult (18 years or older) with certain advanced cancers. The study is currently unclear about its recruitment status, but plans to enroll about 150 participants.

Study design
This is an open-label, Phase 1 study, meaning everyone knows what treatment is being given. It will enroll about 150 participants in two parts: a dose-escalation part and a dose-expansion part.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects for up to 3 years, and for tumor response for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06644755

First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~150 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:DS-2243a

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a
Measured over Up to 18 months
+2 more outcomes measured

Conditions

Solid Tumors
Sarcoma

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Where it's being run

7 sites across 7 states
Massachusetts1
New York1
Tennessee1
Belgium1
France1
Netherlands1
South Korea1

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Avoid donating sperm. Note: Preservation of sperm should be considered prior to enrollment/randomization in this trial.
Adhere to either of the following contraception methods:
True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR
Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential (see Section 10.3.5) PLUS partner use of an additional contraceptive method (see Section 10.3.5.2), as a condom may break or leak. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the trial interventions are more stringent than the requirements above, the local label requirements are to be followed.

What this trial measures

  • Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243aUp to 18 months
  • Part 2: Number of participants with Treatment-Emergent Adverse EventsUp to 3 years

    Descriptive statistics of treatment-emergent adverse events (TEAEs)

  • Part 2: Objective Response RateFrom day of first dose up to 3 years

    Objective Response Rate (ORR) as assessed by the investigator according to RECIST v1.1.