臨床研究等提出・公開システム

PHASE 1/2, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN STUDY OF DS-3939a IN SUBJECTS WITH ADVANCED SOLID TUMORS

First-in-Human Study of DS-3939a in Subjects with Advanced Solid Tumors

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

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

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

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

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Recruiting

Aug. 09, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Sign and date the main Informed Consent Form (ICF), prior to the start of any study-specific qualification procedures.
2. Adults >= 18 years of age on the day of signing the main ICF.
3. Has a left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days of enrollment.
4. Has adequate organ function
5. Measurable disease based on RECIST V1.1.
6. ECOG performance status score of 0 or 1.
Additional inclusion criteria for Part 1
- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.
Additional inclusion criteria for Part 2
- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
- Is able to provide either of the following baseline tumor samples:
a.Fresh core needle biopsy samples obtained during the Main Screening or Tissue Screening Period, or
b.Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the main ICF

1. Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
2. Has spinal cord compression or history of/clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
3. Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for >= 3 years.
4. Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
5. Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and cluster of differentiation 4 (CD4) count.
6. Has evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, as manifested by the detectable viral load (HBV-deoxyribonucleic acid [DNA] or HCV-RNA, respectively).
7. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
8. Has an active, known, or suspected autoimmune disease.
9. Current participation in other therapeutic investigational procedures, except for participation in LTFU without any investigational treatment.

Both

Locally advanced, metastatic, or unresectable solid tumors

Generic name etc : DS-3939a
Dosage and Administration for Investigational material : Dose Escalation Part : IV solution (Once every 3 weeks, initial dose 1 mg /kg), Dose Expansion Part : IV solution (Once every 3 weeks, recommended dose for expansion part)

Dose-limiting toxicities (DLT)
Adverse events (AEs)
Objective Response Rate (Part 2)

Overall Response Rate: ORR
Duration of Response: DoR
Disease Control Rate: DCR
Time to Response: TTR
Progression-free Survival: PFS
Overall Survival: OS
TA-MUC1 Expression by Immunohistochemistry
PK
ADAs for DS-3939a (status and titers)

+81-3-3542-2511

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/

United States/Canada