Study of DS-1123a in Advanced Solid Tumours

Phase 1

Completed

• Conditions: Advanced Solid Malignant Tumors
• Interventions: Drug: DS-1123

• Registration Number: NCT02690337
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DS-1123	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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