Clinical trial · Interventional
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
NCT02690337CI-TRIAL-00036262completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS-1123 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS-1123
- description
- 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.
- interventionNames
- Drug: DS-1123
Primary outcomes (11)
- measure
- Maximum concentration (Cmax)
- timeFrame
- Cycles 1, 2 : Days 1,2, 4, 8, 15
- measure
- Number and severity of treatment emergent adverse events (TEAEs)
- timeFrame
- Day 1 to Day 31
- measure
- Time of maximum concentration (Tmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.