Phase 1 study of DS-8895a

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects with Advanced Solid Tumor

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222257

Enrollment

Registered

2013-10-18

Start date

2013-10-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.

Interventions

investigational material(s) Generic name etc : DS-8895a INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. - ECOG Performance Status(PS)of 0 or 1

Exclusion criteria

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 events, 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.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability, and pharmacokinetics - The safety of DS-8895a will be assessed by CTCAE. - The maximum tolerated dose of DS-8895a, and the recommended dose of DS-8895a for the following clinical studies will be estimated. - Pharmacokinetics of DS-8895a will be evaluated by following the instruction of the study protocol.	—

Secondary

Measure	Time frame
- Incidence of anti-DS-8895a antibody - Exploratory assessment of DS-8895a-related biomarkers - Exploratory assessment of tumor response to DS-8895a - Incidence of anti-DS-8895a antibody is measured by analysis of samples collected from subjects based on the study protocol schedule - Exploratory assessment of DS-8895a-related biomarkers, which are assessed by analysis of samples collected from subjects based on the study protocol schedule - Tumor response will be assessed by RECIST	—

Measure

Time frame

- Incidence of anti-DS-8895a antibody - Exploratory assessment of DS-8895a-related biomarkers - Exploratory assessment of tumor response to DS-8895a - Incidence of anti-DS-8895a antibody is measured by analysis of samples collected from subjects based on the study protocol schedule - Exploratory assessment of DS-8895a-related biomarkers, which are assessed by analysis of samples collected from subjects based on the study protocol schedule - Tumor response will be assessed by RECIST

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026