Open Label Study of DS-5573a

Phase 1TerminatedNCT02192567

Daiichi Sankyo Co., Ltd.19 enrolled

Overview

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Malignant Tumors

Interventions

DS-5573aDRUG

Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg. Step 2: 30 subjects will use the dose determined in Step 1.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. * Eastern Cooperative Oncology Group performance status(PS) of 0 or 1 Exclusion Criteria: * Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment. * Severe or uncontrolled concomitant disease. * Clinically active brain metastases defined as symptomatic or requiring treatment.

Locations (1)

National Cancer Center Hospital

Tokyo, Japan

Outcomes

Primary Outcomes

Number of subjects experiencing dose limiting toxicities

Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.

Time frame: Day 1 through Day 28

Number of subjects experiencing adverse events

Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.

Time frame: Day 1 through 45 days after last dose

Pharmacokinetic profile of DS-5573a

Pharmacokinetic profile of DS-5573a. \[Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1\] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.

Time frame: Cycle 1 - Day 1 through Cycle 8 - Day 1

Secondary Outcomes

Incidence of human anti-human antibodies (HAHA) against DS-5573a

Incidence of human anti-human antibodies (HAHA) against DS-5573a.

Time frame: Cycle 1 - Day 1 through Cycle 1 - Day 15.

Assessment of tumor response to DS-5573a using RECIST ver1.1.

Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.

Time frame: week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90

Assessment of DS-5573a-related biomarkers in blood and tumor

Assessment of DS-5573a-related biomarkers in blood and tumor.

Time frame: Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2

Data from ClinicalTrials.gov

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