Your session is about to expire
← Back to Search
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 belowSelect...
I am 18 years old or older.
Select...
My condition cannot be cured with standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 3 years
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had lung disease that needed steroids, or might have it based on recent scans.I can care for myself and have been stable for two weeks.I am 18 years old or older.I have needed extra oxygen or had serious lung problems in the last 6 months.My organs are functioning well.I have another cancer besides my current one, but it's been under control for less than 3 years.My cancer is advanced or has spread and is one of the specified types, or another type discussed with the Sponsor.I had severe side effects from previous immunotherapy.I have an active hepatitis B or C infection.My condition cannot be cured with standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (DS-1055a)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger