DS-2243a for Solid Tumors

Recruiting at 7 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, DS-2243a (an experimental drug), for individuals with advanced solid tumors, such as certain types of lung cancer, urothelial carcinoma, and sarcomas. The study will assess the drug's tolerability and potential benefits for these conditions. It seeks participants with advanced cancer that has not responded well to standard treatments and who have specific genetic markers, which a doctor can verify. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for previous treatments: less than 4 weeks for radiation therapy, less than 3 weeks for chemotherapy, antibody-based anticancer therapy, or immunotherapy, and less than 2 weeks or 5 half-lives for small molecules, whichever is longer. If you are on chronic steroid treatment or other immunosuppressive medication, you may need to stop or adjust your dosage.

Is there any evidence suggesting that DS-2243a is likely to be safe for humans?

Research shows that DS-2243a is a new treatment under testing to assess its safety and patient tolerance. As this is an early-stage trial, the primary goal is to determine the treatment's safety and potential side effects.

Currently, detailed information on reactions to DS-2243a is limited. At this stage, researchers closely monitor for any side effects, as the treatment is in the initial phase of human safety testing.

Reaching this testing phase indicates that DS-2243a has shown enough promise in lab and animal studies to warrant human trials. However, its effects on humans are still under evaluation. Participants will be closely monitored to ensure safety and manage any side effects.

In summary, while extensive human data is not yet available, the trial aims to assess the safety of DS-2243a for individuals with advanced solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, such as chemotherapy and targeted therapies, DS-2243a is unique because it focuses on a novel mechanism of action. DS-2243a is designed to target specific proteins involved in tumor growth, which could potentially lead to more precise and effective treatment outcomes. Researchers are excited about DS-2243a because it promises to expand treatment options for cancers like urothelial carcinoma and non-small cell lung cancer, offering hope for improved efficacy and fewer side effects compared to current therapies.

What evidence suggests that DS-2243a might be an effective treatment for advanced solid tumors?

Research has shown that DS-2243a is a promising new treatment for various advanced solid tumors. This treatment targets specific markers on cancer cells, commonly found in tumors. DS-2243a is a special type of antibody that helps the immune system recognize and attack cancer cells. Although studies on humans are ongoing, early research indicates that it boosts the body's natural defenses against cancer. In this trial, participants with hard-to-treat cancers, such as bladder cancer, certain types of lung cancer, and specific soft tissue cancers, will receive DS-2243a to evaluate its effectiveness and safety. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain advanced solid tumors, including specific types of lymphoma, sarcoma, and lung or urinary cancer that have not responded to standard treatments. Participants must be able to provide a tissue sample and have an acceptable level of physical function (ECOG PS score of 0 or 1).

Inclusion Criteria

My cancer can be measured on scans.

I can provide a sample of my tumor tissue.

My NSCLC or UC tumor tests positive for NY-ESO protein.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive DS-2243a at escalating doses to determine the recommended dose for expansion

Up to 3 years

Dose Expansion

Participants receive DS-2243a at the recommended dose for expansion in various cancer types

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• DS-2243a

Trial Overview The study is testing DS-2243a's safety and effectiveness in treating advanced solid tumors. It has two parts: first, finding the right dose (dose escalation), then seeing how well it works at that dose.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion UC Experimental Treatment 1 Intervention

Participants with urothelial carcinoma will receive DS-2243a at the recommended dose for expansion (RDE)

Group II: Part 2: Dose Expansion Sq-NSCLC Experimental Treatment 1 Intervention

Participants with squamous cell carcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)

Group III: Part 2: Dose Expansion SS/MRCLS Experimental Treatment 1 Intervention

Participants with synovial sarcoma or myxoid/round cell liposarcoma will receive DS-2243a at the recommended dose for expansion (RDE)

Group IV: Part 2: Dose Expansion Ad-NSCLC Experimental Treatment 1 Intervention

Participants with adenocarcinoma-non-small cell lung cancer will receive DS-2243a at the recommended dose for expansion (RDE)

Group V: Part 1: Dose Escalation DS-2243a Experimental Treatment 1 Intervention

Participants will receive DS-2243a at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06644755

NCT06644755 | First-in-Human Trial of DS-2243a ... This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors. Detailed ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS2668

A phase 1, first-in-human study of DS-2243, an HLA-A*02/ ... DS-2243 is a bispecific antibody and T-cell engager with an effectorless Fc region. It is designed to target HLA-A*02/NY-ESO peptide complexes on tumor cells.

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/DSKYF/pressreleases/35738309/daiichi-sankyos-ds-2243a-a-new-hope-for-advanced-solid-tumors/

Daiichi Sankyo's DS-2243a: A New Hope for Advanced ... ' The study aims to evaluate the safety, tolerability, and clinical efficacy of DS-2243a in treating advanced solid tumors, including sarcoma.

4. daiichisankyo.us daiichisankyo.us/press-releases/-/article/daiichi-sankyo-continues-to-transform-treatment-landscape-for-patients-with-cancer-with-practice-changing-data-at-asco

Press Releases Updated DATROWAY® (datopotamab deruxtecan) combination data across three early-phase trials will be highlighted in patients with early or ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252117/

Immunotherapy through the Lens of Non-Small Cell Lung ... This review article highlights the various types of immunotherapeutic strategies, their modes of action, and the practice-changing clinical trials

6. mskcc.org mskcc.org/cancer-care/clinical-trials/25-045

A Phase 1 Study of DS-2243a in People With Advanced ... The people in this study have these solid tumors, which have spread beyond their original location: Synovial sarcoma; Myxoid/round cell liposarcoma; Urothelial ...

7. careacross.com careacross.com/clinical-trials/trial/NCT06644755

FirstinHuman Trial of DS2243a in Participants With ... This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

8. tipranks.com tipranks.com/news/company-announcements/daiichi-sankyos-ds-2243a-a-new-hope-for-advanced-solid-tumors

Daiichi Sankyo's DS-2243a: A New Hope for Advanced ... ' The study aims to evaluate the safety, tolerability, and clinical efficacy of DS-2243a in treating advanced solid tumors, including sarcoma.

9. withpower.com withpower.com/trial/phase-1-tumors-solid-10-2024-e9954

DS-2243a for 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. Show more.