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Monoclonal Antibodies

DS-1055a for Cancer

Phase 1
Recruiting
Research Sponsored by Daiichi Sankyo Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is 18 years of age or older.
Has a relapsed or refractory disease that is not amenable to curative standard therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 3 years
Awards & highlights

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.

Who is the study for?
Adults with advanced or metastatic solid tumors that have relapsed or are not responding to treatment, and for which there is no standard cure. Participants must be in relatively good physical condition (ECOG PS 0-1), have measurable disease, proper organ function, and provide consent. Excluded are those with a second active cancer (except certain skin/cervical cancers), severe lung conditions, active hepatitis B/C, prior severe immunotherapy side effects, or recent serious respiratory issues.Check my eligibility
What is being tested?
The trial is testing DS-1055a's safety and tolerability on participants with various types of advanced solid tumors like head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer or melanoma. It aims to find out how well patients can handle the drug when other treatments haven't worked.See study design
What are the potential side effects?
While specific side effects for DS-1055a aren't listed here, common ones for similar drugs include immune system reactions leading to inflammation in different body parts; infusion-related symptoms; fatigue; nausea; changes in blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition cannot be cured with standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events
Number of participants with dose-limiting toxicities
Secondary outcome measures
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)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation (DS-1055a)Experimental Treatment1 Intervention
Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.

Find a Location

Who is running the clinical trial?

Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
49,046 Total Patients Enrolled
Clinical Study LeaderStudy DirectorDaiichi Sankyo
29 Previous Clinical Trials
3,617 Total Patients Enrolled

Media Library

DS-1055a (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04419532 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation (DS-1055a)
Solid Tumors Clinical Trial 2023: DS-1055a Highlights & Side Effects. Trial Name: NCT04419532 — Phase 1
DS-1055a (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419532 — Phase 1
~6 spots leftby Dec 2024
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