First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

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NCT05875168 · readout in 62 d

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

590estimated

Sites

Countries

Belgium, Canada, China +5

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-08-18

actual

When the study began enrolling

Primary completion

2026-10-20

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-02-15

estimated

The whole study's end, after follow-up

First posted

2023-05-25

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-12

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor

Intervention

Drug: DS-3939a

Primary outcomes

what the primary-completion date above is the date OF

Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a

measured Approximately 3 months after first dosing

Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a

measured Up to approximately 31 months

Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)

measured Up to approximately 31 months

PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)

measured Up to approximately 31 months

Publications

PMID 40635151 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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