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

JRCT ID: jRCT2031220075

Registered date:19/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced Renal Cell Carcinoma and Ovarian Tumors
• Date of first enrollment: 13/06/2022
• Target sample size: 140
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

- Dose-limiting toxicities (DLTs)
- Serious adverse events (SAEs)
- Treatment-emergent adverse events (TEAEs)
- Adverse events of special interest (AESIs)
- Overall response rate (ORR) for expansion

Secondary Outcome

- Plasma PK parameters
- Overall response rate (ORR) for escalation, duration of response(DoR), disease control rate (DCR), clinical benefit rate (CBR), time to response (TTR), progression-free survival (PFS)
- ADAs (titers and status)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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, DS-1062a, DS-7300a)
- 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 serious cardiac arrhythmia requiring treatment
- Lung-specific intercurrent clinically significant illnesses
- Has an uncontrolled infection requiring systemic therapy

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Secondary ID(s): NCT04707248