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Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects with Advanced Renal Cell Carcinoma and Ovarian Tumors

Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects with Advanced Renal Cell Carcinoma and Ovarian 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

May. 31, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Written informed consent
- At least 18 years of age
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1
- Availability of archived tumor tissue samples
- Has a left ventricular ejection fraction (LVEF) >=50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before start of study treatment
- Has adequate organ function within 7 days before the start of study treatment
- Has an adequate treatment washout period prior to start of study treatment
- Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug

- Has had prior treatment with other CDH6-targeted agents
- Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, datopotamab deruxtecan, ifinatamab deruxtecan, DS-3939)
- Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery >=2 weeks before the start of study treatment and have no evidence of disease progression in the CNS and no requirement for chronic corticosteroid therapy within 2 weeks before the start of study treatment
- 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 a history of myocardial infarction or unstable angina within 6 months before start of study treatment
- Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia requiring treatment
- Lung-specific intercurrent clinically significant illnesses
- Has an uncontrolled infection requiring systemic therapy

Both

Advanced Renal Cell Carcinoma and Ovarian Tumors

Dose Escalation (Part A)
Intravenous administration every 3 weeks at doses starting at 1.6 mg/kg
Dose Expansion (Part B)
Intravenous administrationevery 3 weeks at RDE

- Number of Participants With Dose-limiting toxicities (DLTs)
- Number of Participants Reporting Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
- Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)
ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).

- Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve from Time Zero to 21 Days (AUC 21d) for R-DXd and its Metabolites
- Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve Up to the Last Quantifiable Time (AUClast) for R-DXd and its Metabolites
- Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) for R-DXd and its Metabolites
- Pharmacokinetic Analysis Lowest Plasma Concentration (Ctrough) for R-DXd and its Metabolites
- Pharmacokinetic Analysis Time to Maximum Plasma Concentration (Tmax) for R-DXd and its Metabolites
- Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator and Blinded Independent Central Review (Dose Escalation)
ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
- Duration of Response (DoR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
DoR is defined as the duration from the first documented response to the date of progression or death due to any cause.
- Disease Control Rate (DCR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
DCR is defined as the proportion of participants with BOR of CR, PR, or SD.
- Clinical Benefit Rate (CBR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
CBR is defined as the proportion of participants with BOR of CR or PR, or participants with stable disease (SD) lasting at least 180 days.
- Time to Response (TTR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
- Progression-free Survival Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review
- Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA

+81-3-3542-2511

May. 11, 2022

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