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New hope for Hard-to-Treat cancers?

NCT ID NCT04419532

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called DS-1055a in about 40 adults with advanced solid tumors (like head and neck, stomach, or lung cancer) that have come back or spread and no longer respond to standard treatments. The main goal is to check the drug's safety and find the right dose. This is a first-in-human trial, so it focuses on side effects and how the drug moves through the body, not on curing the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550, Japan

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2C1, Canada

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219, United States

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