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New hope for advanced tumors? first human trial of DS-3939a begins

NCT ID NCT05875168

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This early-phase study tests a new drug called DS-3939a in about 540 people with advanced solid tumors that have spread or cannot be removed. The main goals are to check safety and see if the drug shrinks tumors. Participants must have measurable disease and good organ function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional inclusion criteria for Part 1 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional inclusion criteria for Part 2 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria * Is able to provide either of the following baseline tumor samples: 1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or * Fresh core needle biopsy sample * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual. 2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample. Exclusion Criteria: * Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. * Has spinal cord compression or clinically active central nervous system metastases. * Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years. * Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. * Has active or uncontrolled human immunodeficiency virus (HIV) infection. * Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection. * Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. * Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    WITHDRAWN

    Seoul, 05505, South Korea

  • Assistance Publique- de Marseille

    RECRUITING

    Marseille, 13005, France

  • Beijing Cancer Hospital

    NOT_YET_RECRUITING

    Beijing, 100142, China

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • Chu Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari Vall D'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata-shi, 573-1191, Japan

  • Kindai University Hospital

    RECRUITING

    Ōsaka-sayama, 589-8511, Japan

  • McGill University Health Center

    NOT_YET_RECRUITING

    Montreal, H4A 3J1, Canada

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Next Madrid

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, 541-8567, Japan

  • Princess Margaret Cancer Center

    ACTIVE_NOT_RECRUITING

    Toronto, M5G2M9, Canada

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sendai Kousei Hospital

    RECRUITING

    Sendai, 981-0914, Japan

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, 250117, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • The Medical College of Wisconsin, INC

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • The Second Peoples Hospital of Neijiang

    RECRUITING

    Neijiang, 641000, China

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of Kansas Medical Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.