A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
About the study
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 take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor,Advanced Cancer,Metastatic Solid Tumor
Age
18+
Phase
PHASE1
Participants Needed
40
Est. Completion Date
Dec 31, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Daiichi Sankyo
ClinicalTrials.gov NCT Identifier
NCT04419532
Study Number
DS1055-A-J101
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?