Phase 1 study of DS-3032b

A phase 1 Multiple Ascending Dose Study of DS-3032b, an Oral MDM2 Inhibitor, in Japanese Subjects with Advanced Solid Tumors or Lymphomas

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222642

Enrollment

Registered

2014-11-04

Start date

2015-01-14

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 tumors or lymphomas that are refractory to standard therapy or for which no standard therapy is available.

Interventions

investigational material(s) Generic name etc : DS-3032b INN of investigational material : Milademetan Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Advanced solid tumors or lymphomas that are refractory to standard therapy or for which no standard therapy is available. -An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion criteria

Exclusion criteria: -Previously had or currently has any of the following diseases: Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral bypass surgery, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment. -Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia). -Severe or uncontrolled concomitant disease. -Clinically active brain metastases, which are symptomatic or requiring treatment. -Has a second concurrent primary malignancy such as solid tumor or lymphoma.

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics Safety, tolerability, and pharmacokinetics -The safety of DS-3032b will be assessed by CTCAE. -The maximum tolerated dose of DS-3032b, and the recommended dose of DS-3032b for the following clinical studies will be estimated. -Pharmacokinetics of DS-3032b will be evaluated by following the instruction of the study protocol.	—

Secondary

Measure	Time frame
pharmacodynamics -Pharmacodynamic effect of DS-3032b. -Exploratory assessment of tumor or hematologic response. -Exploratory assessment of the relationship between tumor response to DS-3032b and predictive biomarkers. -Pharmacodynamic effect of DS-3032b and exploratory assessment of DS-3032b-related biomarkers will be assessed by analysis of samples collected from subjects based on the study protocol schedule. -Tumor response will be assessed by RECIST ver 1.1 or revised IWG criteria.	—

Measure

Time frame

pharmacodynamics -Pharmacodynamic effect of DS-3032b. -Exploratory assessment of tumor or hematologic response. -Exploratory assessment of the relationship between tumor response to DS-3032b and predictive biomarkers. -Pharmacodynamic effect of DS-3032b and exploratory assessment of DS-3032b-related biomarkers will be assessed by analysis of samples collected from subjects based on the study protocol schedule. -Tumor response will be assessed by RECIST ver 1.1 or revised IWG criteria.

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Countries

Japan

Outcome results

None listed

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