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Advanced Solid TumorPhase 1/2NCT05875168

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

A Phase 1/2 study testing DS-3939a in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Daiichi Sankyo at 61 sites in 8 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 study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
DS-3939a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
61 sitesin 8 countries
Study dates
18 Aug 2023to 11 Nov 2028
Phase
Phase 1/2
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 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
Show all 14Show fewer
  • 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:
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

61 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo@dsi.com

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information contact

+81-3-6225-1111 (M-F 9-5 JST)

dsclinicaltrial_jp@daiichisankyo.com

61 sites in 8 countries

United States14 sites, 8 recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Withdrawn

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Principal Investigator

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Withdrawn

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Piedmont Cancer Institute

    Locust Grove, Georgia, 30248

    Withdrawn

  • The Medical College of Wisconsin, INC

    Milwaukee, Wisconsin, 53226

    Recruiting

  • The Medical College of Wisconsin, INC

    Milwaukee, Wisconsin, 53226

    Withdrawn

  • Icahn School of Medicine Mt Sinai

    New York, New York, 10029

    Withdrawn

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Principal Investigator

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Principal Investigator

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Withdrawn

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Principal Investigator

    Recruiting

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

China13 sites, 7 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Withdrawn

  • Jilin Cancer Hospital

    Changchun, 130000

    Withdrawn

  • Hunan Cancer Hospital

    Changsha, 410013

    Withdrawn

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330209

    Recruiting

  • The Second Peoples Hospital of Neijiang

    Neijiang, 641000

    Recruiting

  • Shanghai East Hospital

    Shanghai, 200120

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

    Withdrawn

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

    Withdrawn

  • The First Affiliated Hospital of Xiâan Jiaotong University

    Xi'an, 710061

    Withdrawn

  • Xiangyang Central Hospital

    Xiangyang, 441021

    Recruiting

Other trials in China

Japan10 sites, 10 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    See Central Contact

    Recruiting

  • Kansai Medical University Hospital

    Hirakata-shi, 573-1191

    Principal Investigator

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    See Central Contact

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550

    Recruiting

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

    Principal Investigator

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

    Recruiting

  • Nho Hokkaido Cancer Center

    Sapporo, 003-0804

    Principal Investigator

    Recruiting

  • Sendai Kousei Hospital

    Sendai, 981-0914

    Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777

    Principal Investigator

    Recruiting

Other trials in Japan

France8 sites, 6 recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Withdrawn

  • Assistance Publique- de Marseille

    Marseille, 13005

    Recruiting

  • Ico - Site René Gauducheau

    Saint-Herblain, 44800

    Recruiting

  • Chu Strasbourg

    Strasbourg, 67091

    Withdrawn

  • Institut Claudius Regaud

    Toulouse, 31059

    Principle Investigator

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Spain7 sites, 6 recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

    Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Withdrawn

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Next Madrid

    Pozuelo de Alarcón, 28223

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

Other trials in Spain

South Korea6 sites, 4 recruiting

  • National Cancer Center

    Goyang, 10408

    Site Coordinator

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Withdrawn

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Withdrawn

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Canada2 sites, 1 recruiting

  • McGill University Health Center

    Montreal, H4A 3J1

    Withdrawn

  • Princess Margaret Cancer Center

    Toronto, M5G2M9

    Recruiting

Other trials in Canada

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

About this study

Official title: Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Read the detailed description

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Being tested
DS-3939a
Keywords
DS-3939a, Advanced/metastatic solid tumors, Antibody drug conjugate
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • DS-3939aDrug

    One IV infusion Q3W on Day 1 of each 21-day cycle

Study groups in NCT05875168
Study groupRoleWhat they receive
Dose Escalation (Part 1)ExperimentalParticipants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a starting at 1 mg/kg.
Receives: Drug: DS-3939a
Dose Expansion (Part 2)ExperimentalMultiple expansion cohorts targeting various advanced solid tumors.
Receives: Drug: DS-3939a

What is being measured

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

  1. Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a

    Measured: Approximately 3 months after first dosing

  2. Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  3. Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)

    Measured: Up to approximately 31 months

  4. PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)

    Measured: Up to approximately 31 months

Secondary outcomes (18)

  1. Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)

    Measured: Up to approximately 31 months

  2. Disease Control Rate Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  3. Duration of Response Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  4. Time to Response Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  5. Progression Free Survival Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  6. Overall Survival Following Treatment With DS-3939a

    Measured: Up to approximately 31 months

  7. TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a

    Measured: At Cycle 1 Day 1

  8. Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a

    Measured: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  9. Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a

    Measured: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  10. Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a

    Measured: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  11. Minimum Observed Concentration (Ctrough) Following Treatment With DS-3939a

    Measured: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  12. Terminal Half-Life (T1/2) Following Treatment With DS-3939a

    Measured: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  13. Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a

    Measured: Up to approximately 47 months

  14. PSA50 Response Rate Following Treatment with DS-3939a (Part 1; CRPC only)

    Measured: Up to approximately 31 months

  15. PSA30 and PSA90 Response Rate Following Treatment with DS-3939a (CRPC only)

    Measured: Up to approximately 31 months

  16. Time to PSA Progression Following Treatment with DS-3939a (CRPC only)

    Measured: Up to approximately 31 months

  17. Radiographic Progression-free Survival (PCWG 3) Following Treatment with DS-3939a (CRPC only)

    Measured: Up to approximately 31 months

  18. Overall Survival Following Treatment with DS-3939a (CRPC only)

    Measured: Up to approximately 31 months

Timeline

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

  1. First posted25 May 2023
  2. Study start18 Aug 2023
  3. Primary completion11 Aug 2028 (estimated)
  4. Study completion11 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875168
Sponsor's protocol ID
DS3939-077
Other IDs
2023-507937-14-00, 2023
Status last verified
Oct 2026
First submitted
10 May 2023
Last updated
15 Oct 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/

Publications

  • Takano K, Yukiura M, Takahashi K, Kitamura M, Okuno H, Shiose Y, Honda K, Oyama K, Yamada M, Obuchi W, Kumagai K, Sakurai K, Goto R, Zembutsu A, Kagari T, Abe Y, Agatsuma T. DS-3939a: A TA-MUC1-Directed Antibody-Drug Conjugate with Broad Antitumor Activity. Mol Cancer Ther. 2026 Jan 2;25(1):7-20. doi: 10.1158/1535-7163.MCT-24-0666.

    PubMed 40635151

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DS-3939a in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Daiichi Sankyo at 61 sites in 8 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 14 inclusion and 9 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, China, Japan, France, Spain and 3 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (US Sites) Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo@dsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a (time frame: Approximately 3 months after first dosing). The study lists 4 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 NCT05875168, which also lists 1 linked publication.

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 15 Oct 2026.

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