Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Solid Tumor
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 i...
Detailed Description
This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04419532
Start Date
October 9 2020
End Date
January 31 2026
Last Update
April 9 2025
Active Locations (6)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45219
3
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2C1
4
National Cancer Center Hospital
Chūōku, Japan, 104-0045