Open Label Study of DS-5573a

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of DS-1123a in Advanced Solid Tumours

NCT02690337

Advanced Solid Malignant Tumors

COMPLETED PHASE1

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900

Advanced Solid Tumors

COMPLETED PHASE1

Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

NCT02004717

Solid Tumors

COMPLETED PHASE1

A Study of EMD525797 in Solid Tumor Patients in Japan

NCT01327313

Solid Tumor

COMPLETED PHASE1

A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

NCT04419532

Solid Tumor Advanced Cancer Metastatic Solid Tumor

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Malignant Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DS-5573a does escalation (step 1) and expansion (step 2)

Step 1 of this study will follow a 3+3 study design with 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 be enrolled and treated at the dose determined in Step 1.

Group Type EXPERIMENTAL

DS-5573a

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DS-5573a

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No