Who is eligible for clinical trial NCT04419532?

Participants must meet protocol criteria for Solid Tumor. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04419532 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-18

A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors (NCT04419532)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: Memorial Sloan Kettering Cancer Center — New York, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗