A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Solid Tumor, Advanced Cancer, Metastatic Solid Tumor

In brief

The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available.

Key facts

Study ID

NCT04419532

Run by

Daiichi Sankyo

People needed

40

Starts

2020-10-09

Expected to finish

2027-07-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for <3 years.
• Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
• Has a history of severe pulmonary compromise or requirement of supplemental oxygen within 6 months before enrollment.
• Has active hepatitis B or hepatitis C virus infection.
• Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2 immune-related adverse event.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Cincinnati Cancer Center — Cincinnati, Ohio, United States
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• National Cancer Center Hospital — Chūōku, Japan
• National Cancer Center Hospital East — Kashiwa, Japan
• Cancer Institute Hospital of JFCR — Kōtoku, Japan

Full record on ClinicalTrials.gov

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