Clinical trial · Interventional
Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors
Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects With Advanced Solid Tumors
NCT02004717CI-TRIAL-00039609completedPhase 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, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a 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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS-8895a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose escalation then expansion
- description
- Dose escalation of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Six dose levels are planned: level 1,0.1 mg/kg; level 2,0.3 mg/kg; level 3, 1.0 mg/kg; level 4,3.0 mg/kg; level 5,10 mg/kg; level 6,20 mg/kg. Dose Expansion - Up to 20 subjects will be enrolled and treated at the dose determined in Dose Escalation arm.
- interventionNames
- Drug: DS-8895a
Primary outcomes (3)
- measure
- number of participants experiencing dose limiting toxicities
- timeFrame
- day 1 through day 28
- description
- to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events
- measure
- number of participants experiencing clinical or laboratory adverse events
- 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 (1)
- DERIVEDShitara K, Satoh T, Iwasa S, Yamaguchi K, Muro K, Komatsu Y, Nishina T, Esaki T, Hasegawa J, Kakurai Y, Kamiyama E, Nakata T, Nakamura K, Sakaki H, Hyodo I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors. J Immunother Cancer. 2019 Aug 14;7(1):219. doi: 10.1186/s40425-019-0679-9. PMID 31412935