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Solid TumorsPhase 1NCT06644755

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

A Phase 1 study testing DS-2243a in people with Solid Tumors and Sarcoma, run by Daiichi Sankyo at 7 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Sarcoma
What is being tested?
DS-2243a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
7 sitesin 5 countries
Study dates
14 Nov 2024to 30 Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign and date the main ICF.
  • Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first.
  • Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
  • One of the following histologically or cytologically documented cancers:
  • Advanced (metastatic or unresectable) SS Advanced (metastatic or unresectable) MRCLS Metastatic or unresectable locally advanced NSCLC (Ad/Sq) Metastatic or unresectable locally advanced UC
  • 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.]
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  • 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.
  • Meets the following required baseline local laboratory data within 14 days prior to start of trial intervention administration:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN) in participants with no liver metastasis, or ≤5 × ULN in participants with liver metastasis
  • Total bilirubin (TBL) ≤1.5 × ULN (≤3 × ULN for participants with a documented history of Gilbert's syndrome)
  • Absolute neutrophil count (ANC) ≥1.5 × 10^9/L
  • Platelet count ≥100 × 10^9/L
  • Hemoglobin ≥8 g/dL
  • Creatinine clearance (CrCl) ≥45 mL/min as calculated using the Cockcroft-Gault equation (Section 10.3.1)
  • Note: Any blood or blood product transfusion is allowed up to 7 days before the hematology evaluations and any dose of hematologic growth factor is allowed up to 14 days before the hematology evaluations.
  • a) A female participant of childbearing potential (CBP), as defined in Section 10.3.5.1, is eligible to participate if the following conditions are met: Participant is not pregnant as confirmed by highly sensitive pregnancy test (see Section 10.3.5.3). Participant does not breastfeed during the trial intervention period and for at least 120 days after last dose of trial intervention. Participant agrees to adhere to a contraceptive method that is highly effective (Section 10.3.5.2) and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the intervention period and for at least the time needed to eliminate the trial intervention after the last dose. The length of time required to continue contraception after last dose for the trial intervention is 120 days. Preservation of eggs may be considered prior to first dose of trial intervention.
  • A male participant capable of producing sperm is eligible to participate if he agrees to the following during the Treatment Period and for at least the time needed to eliminate the trial intervention. The length of time required to continue contraception after the last dose of the trial intervention is 120 days.
  • 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.
  • Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.

Who cannot join

  • 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.
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  • MRI/CT of the brain is required for all participants during Screening Period (see Section 8.3.1).
  • Uncontrolled or clinically significant cardiovascular disease, including the following:
  • Myocardial infarction within 6 months prior to screening
  • Uncontrolled angina pectoris within 6 months prior to screening
  • New York Heart Association (NYHA) Class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) ≤50% or lower than the institutional lower limit of normal
  • QT interval corrected with Fridericia's formula (QTcF) interval >480 ms
  • Chronic steroid treatment (IV or oral) or any other immunosuppressive medication (ie, prednisone >10 mg daily (QD) or the equivalent).
  • Has active other primary malignancies. Note: Participants with the following can be enrolled: Adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal tract curatively resected by endoscopic surgery, or any other solid tumors curatively treated with no evidence of recurrent disease for ≥3 years and requires no treatment.
  • Has unresolved toxicities from previous anticancer treatment, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Note: Participants with chronic, stable Grade 2 toxicities (defined as no worsening for 1 month prior to enrollment and managed with SOC treatment) that the investigator deems related to previous anticancer treatment may be enrolled. Such toxicities may include the following:
  • Chemotherapy-induced peripheral neuropathy
  • Residual toxicities from prior immuno-oncology treatment:
  • Grade 2 endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycemia due to type 1 diabetes mellitus) with adequate therapy Grade 2 skin hypopigmentation (vitiligo)
  • Has known hypersensitivity to biological agents.
  • Has a history of or active autoimmune disease.
  • Note: Participants with the following examples may be enrolled as an exception:
  • Type I diabetes mellitus/hypothyroidism only requires hormone replacement.
  • Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
  • Has human immunodeficiency virus (HIV) infection. Participants must be tested for HIV viral load during the Screening Period if acceptable by local regulations or Institutional Review Boards/Independent Ethics Committees (IRBs/IECs).
  • Note: For Part 2 only, the following participants will be eligible:
  • Have CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
  • Have virologic suppression, defined as confirmed HIV RNA level below 50 or the lower limit of quantitation (below the limit of detection) at the time of screening and for at least 12 weeks before screening.
  • Have no acquired immunodeficiency syndrome-defining opportunistic infections or conditions within the past 12 months.
  • Are on stable antiretroviral therapy regimen, without changes in drugs or dose modification, for at least 4 weeks before trial entry (Day 1) and agree to continue antiretroviral therapy throughout the trial, as defined per institutional protocol.
  • Has active or uncontrolled hepatitis B or C infection as defined per institutional guidelines.
  • Note: For Part 2 only, the following participants will be eligible:
  • Hepatitis B surface antigen (HBsAg)-positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation (participants should remain on antiviral therapy throughout trial intervention and follow local guidelines for HBV antiviral therapy after completion of trial intervention).
  • Have a history of hepatitis C infection and hepatitis C virus (HCV) viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.
  • Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT <3 × ULN, which are not attributable to HCV infection.

Trial locations and contacts

7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Contact for Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

7 sites in 5 countries

United States3 sites, 3 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

Other trials in United States

Belgium1 site, 1 recruiting

  • UZ Leuven Europe Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

France1 site, 1 recruiting

  • Centre Leon Berard

    Lyon, 6900

    Recruiting

Other trials in France

Netherlands1 site, 1 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

    Amsterdam

    Recruiting

Other trials in Netherlands

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

Other trials in South Korea

About this study

Official title: Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in Participants With Advanced Solid Tumors

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

Read the detailed description

This is a global, multicenter, open-label, first-in-human, Phase 1 trial of DS-2243a as a treatment for locally advanced or metastatic synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCLS), squamous cell carcinoma type non-small cell lung cancer (Sq-NSCLC), adenocarcinoma type non-small cell lung cancer (Ad-NSCLC), or urothelial carcinoma (UC) participants with HLA-A2 and/or NY-ESO positive. The trial consists of 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Being tested
DS-2243a
Keywords
synovial sarcoma, ny-eso-1, DS-2243a, Myxoid Round cell Liposarcoma, sarcoma, NSCLC, UC, Bladder Cancer, NY-ESO, HLA-A2, Advanced solid tumors
Medical subject headings
Sarcoma, Sarcoma, Synovial, Liposarcoma, Myxoid, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-2243aDrug

    Escalation Part: DS-2243a will be administered at escalating doses to determine the RDE

    Expansion Part: DS-2243a will be administered at RDE

Study groups in NCT06644755
Study groupRoleWhat they receive
Part 1: Dose Escalation DS-2243aExperimentalParticipants will receive DS-2243a at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.
Receives: Drug: DS-2243a
Part 2: Dose Expansion SS/MRCLSExperimentalParticipants with synovial sarcoma or myxoid/round cell liposarcoma will receive DS-2243a at the recommended dose for expansion (RDE)
Receives: Drug: DS-2243a
Part 2: Dose Expansion Sq-NSCLCExperimentalParticipants with squamous cell carcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)
Receives: Drug: DS-2243a
Part 2: Dose Expansion UCExperimentalParticipants with urothelial carcinoma will receive DS-2243a at the recommended dose for expansion (RDE)
Receives: Drug: DS-2243a
Part 2: Dose Expansion Ad-NSCLCExperimentalParticipants with adenocarcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)
Receives: Drug: DS-2243a

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 18 months

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

    Descriptive statistics of treatment-emergent adverse events (TEAEs)

    Measured: Up to 3 years

  3. Part 2: Objective Response Rate

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

    Measured: From day of first dose up to 3 years

Secondary outcomes (5)

  1. Part 1: Objective Response Rate

    ORR as assessed by the investigator according to RECIST v1.1.

    Measured: From day of first dose up to 3 years

  2. Disease Control Rate

    Disease Control Rate (DCR) as assessed by the investigator according to RECIST v1.1.

    Measured: From day of first dose up to 4 years.

  3. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) as assessed by the investigator according to RECIST v1.1.

    Measured: From day of first dose up to 4 years

  4. Overall Survival

    Measured: From day of first dose up to 4 years

  5. Drug Plasma Concentration

    Measured: Days 1, 2, and 3 during step-up dosing; Days 1, 2, 3, 5, 8, and 15 of Cycles 1 and 3; Day 1 of Cycle 2; and Day 1 of Cycle 4 and each subsequent cycle. A cycle may be up to 36 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is an open-label study.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644755
Sponsor's protocol ID
DS2243-054
Status last verified
Sep 2026
First submitted
4 Oct 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-2243a in people with Solid Tumors and Sarcoma, run by Daiichi Sankyo at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Belgium, France, Netherlands, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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