New hope for Hard-to-Treat cancers?
NCT ID NCT04419532
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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National Cancer Center Hospital
Chūōku, 104-0045, Japan
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National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
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Princess Margaret Cancer Center
Toronto, Ontario, M5G 2C1, Canada
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University of Cincinnati Cancer Center
Cincinnati, Ohio, 45219, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- Two-Drug combo targets stubborn KRAS lung cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?