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_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

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)
2. Has a left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days of enrollment.
3. Has adequate organ function
4. Measurable disease based on RECIST V1.1.
5. 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.

1. Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
2. Has spinal cord compression or clinically active central nervous system (CNS) metastases.
3. 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.
4. 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.
5. Has active or uncontrolled human immunodeficiency virus (HIV) infection.
6. Has evidence of active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
7. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
8. Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease.
9. Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up (LTFU) without any investigational treatment.

Both

Advanced Solid Tumor, Metastatic Solid Tumor

Generic name etc : DS-3939a
Dosage and Administration for Investigational material : Dose Escalation Part : IV solution (Once every 3 weeks, starting at 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)
PSA50 Response Rate (Part 2; CRPC only)

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)
PSA50 Response Rate (Part 1; CRPC only)
PSA30 and PSA90 Response Rate (CRPC only)
Time to PSA Progression (CRPC only)
Radiographic Progression-free Survival (PCWG 3) (CRPC only)
Overall Survival (CRPC only)

+81-3-3542-2511

July. 26, 2023

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/

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