A Phase 1, first in human study of DS-1055a in subjects with relapsed or refractory locally advanced or metastatic solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225196

Enrollment

Registered

2020-05-20

Start date

2020-10-09

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

locally advanced or metastatic head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer, or melanoma

Interventions

investigational material(s) Generic name etc : DS-1055a INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Has a histopathologically documented locally advanced or metastatic head and neck, gastric, or esophageal cancer, non-small cell lung cancer, or melanoma. Participants with other types of solid tumors may be eligible following discussion with the Sponsor. 2. Has a relapsed or refractory disease that is not amenable to curative standard therapy. 3. Is 18 years of age or older. 4. Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, with no deterioration for two weeks. 5. Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. Has adequate organ function within 7 days. 7. Is able to provide written informed consent and is willing and able to comply with the protocol.

Exclusion criteria

Exclusion criteria: 1. Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with history of the second malignancy have been disease-free for =Grade 2 immune-related adverse event.

Design outcomes

Primary

Measure	Time frame
safety - To assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose of DS-1055a for further investigation	—

Secondary

Measure	Time frame
other pharmacokinetics - To assess pharmacokinetic (PK) properties of DS-1055a - To assess the incidence of anti-drug antibodies (ADA) against DS-1055a and of other antibodies.	—

Countries

Japan, North America

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

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