DS-1055a for Solid Tumors

National Cancer Center Hospital East, Kashiwa, Japan
Solid Tumors+2 More ConditionsDS-1055a - Drug
All Sexes

Study Summary

This trial is testing a new drug for people with cancer that has no standard treatment. The goal is to see if it is safe and tolerated.

Eligible Conditions
  • Solid Tumors
  • Solid Metastatic Tumor
  • Advanced Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Baseline up to approximately 3 years

Day 21
Number of participants with dose-limiting toxicities
Year 3
Number of participants with adverse events
Year 2
Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
Maximum Serum Concentration (Cmax)
Time to Reach Maximum Serum Concentration (Tmax)
Year 2
The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies
Year 2
Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
Maximum Plasma Concentration (Cmax)
Minimum Observed Concentration (Ctrough)
Time to Reach Maximum Plasma Concentration (Tmax)

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Dose Escalation (DS-1055a)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: DS-1055a · No Placebo Group · Phase 1

Dose Escalation (DS-1055a)
Experimental Group · 1 Intervention: DS-1055a · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 3 years

Who is running the clinical trial?

Daiichi Sankyo Co., Ltd.Lead Sponsor
113 Previous Clinical Trials
48,676 Total Patients Enrolled
Clinical Study LeaderStudy DirectorDaiichi Sankyo, Inc.
29 Previous Clinical Trials
3,615 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a disease that has returned after treatment or is not responding to standard treatments that can cure it.
You have been diagnosed with advanced or spreading cancer in your head and neck, stomach, esophagus, lungs or skin. In some cases, you may still be considered for the trial even if you have a different type of cancer, but only after talking to the Sponsor.

Frequently Asked Questions

Has DS-1055a been accepted for regulatory use by the Food and Drug Administration?

"Due to the limited data available, DS-1055a's safety rating is 1. This reflects it being a Phase One trial with little evidence of efficacy and security." - Anonymous Online Contributor

Unverified Answer

Are there any openings in this clinical experiment available to participants?

"Affirmative. According to the clinicaltrials.gov database, this experiment is presently seeking out participants and has been accepting applications since October 9th 2020. The most up-to-date update was on November 28th 2022. 40 patients need to be recruited from a single site for this trial." - Anonymous Online Contributor

Unverified Answer

How many participants are taking part in this clinical research?

"Affirmative. The information contained on clinicaltrials.gov confirms that this experiment, which was initially published on October 9th 2020, is actively recruiting participants. Approximately 40 people need to be enrolled from a single medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.