Study of DS-1123a in Advanced Solid Tumours

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Malignant Tumors
• Intervention / Treatment: Drug: DS-1123

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 277-8577

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),

• Severe or uncontrolled concomitant disease.
• Clinically active brain metastases defined as symptomatic or requiring treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS-1123; This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg.	Drug: DS-1123; starting intravenous (IV) dose of 0.1 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax)		Cycles 1, 2 : Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)		Day 1 to Day 31
Time of maximum concentration (Tmax)		Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)		Cycles 1, 2: Days 1,2, 4, 8, 15
area under the curve AUClast	pharmacokinetics profile	Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCtau)		Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCinf)		Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)		Cycles 1, 2: Days 1,2, 4, 8, 15
Drug clearance (CL)		Cycles 1, 2: Days 1,2, 4, 8, 15
Volume of distribution (Vz)		Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)		Cycles 1, 2: Days 1,2, 4, 8, 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DS-1123a antibody	DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date	Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Change in Cytokines expression	Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2	Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: oncology; phase 1; refractory; Advanced solid malignant tumors; no standard treatment
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DS1123-A-J101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) 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/
• IPD Sharing Time Frame: Studies 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.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR