臨床研究等提出・公開システム

A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants with Advanced Solid Tumors

First-in-Human Trial of DS1025a in Participants with Advanced Solid Tumors

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

Recruiting

July. 27, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Sign and date the main ICF, prior to the start of any trial-specific procedures.
2. Adults >=18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
3. Histologically documented, advanced, metastatic, or unresectable solid tumors.
4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.
5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.
6. Has measurable disease based on local CT/MRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.
7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.
8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.
9. A WOCBP is eligible to participate if the following conditions are met:
- Participant is not pregnant as confirmed by highly sensitive pregnancy test
- Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.
- Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.
10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:
- Avoid donating sperm.
- Adhere to approved contraception method as specified in the protocol.

1. Prior treatment with an anti-CD25 therapy.
2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).
3. Inadequate washout period before initiation of trial intervention as specified in the protocol.
4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
5. Uncontrolled or significant cardiovascular disease as specified in the protocol.
6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
7. Participants with any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.
8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.
9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.
10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate >90%) and treated with expected curative outcome
11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade <=1 or baseline.
12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.
13. Has a known history of HLH.
14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.
15. Has active or uncontrolled HBV infection.
16. Has active or uncontrolled HCV infection.
17. Has active or uncontrolled HIV infection.
18. Has an active, known, or suspected autoimmune disease.
19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.

Both

Advanced Solid Tumor, Metastatic Solid Tumor, Unresectable Solid Tumor

Experimental: Dose Escalation: DS1025a
Participants with advanced, metastatic, or
unresectable solid tumors will receive DS1025a on Day 1.

1. Number of Participants Reporting Dose-limiting Toxicities (DLTs)
[Time Frame: Day 1 up to approximately 12 months]

2. Number of Participants Reporting Adverse Events (AEs)
[Time Frame: Screening up to long-term survival follow up every 12 weeks, up to approximately 12 months]

3. Number of Participants Reporting Discontinuation of DS1025a Due to AEs
[Time Frame: Screening up to long-term survival follow up every 12 weeks, up to approximately 12 months]

1. Pharmacokinetic Parameter Area Under the Plasma-Concentration Curve (AUC)
Area under the curve over the dosing interval (AUCtau) and Area under the plasma concentration-time curve up to the
last quantifiable time (AUClast) will be assessed.
[Time Frame: Predose up to approximately 12 months]

2. Pharmacokinetic Parameter Maximum Concentration (Cmax)
[Time Frame: Predose up to approximately 12 months]

3. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
[Time Frame: Predose up to approximately 12 months]

4. Pharmcokinetic Parameter Concentration at Trough Level (Ctrough)
[Time Frame: Predose up to approximately 12 months]

5. Percentage of Participants Who Are ADA Positive and Percentage of Participants Who Have Treatment-emergent ADAs
[Time Frame: Day 1 up to approximately 12 months]

+81-3-6665-0572

July. 08, 2026

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/ Supporting Information: -Study Protocol -Statistical Analysis Plan (SAP) -Informed Consent Form (ICF) Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

none