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Monoclonal Antibodies
DS-3939a for Advanced Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 47 months
Awards & highlights
Study Summary
This trial looks at a new treatment to see if it's safe, tolerated, and effective for people with advanced cancer.
Who is the study for?
This trial is for adults with advanced solid tumors, including specific types such as urothelial, lung, breast, ovarian, biliary tract cancers or pancreatic cancer. Participants must have measurable disease and be in good physical condition (performance status of 0 or 1). They should not have autoimmune diseases, other ongoing clinical study commitments, prior treatments targeting MUC1 protein or a history of certain serious medical conditions.Check my eligibility
What is being tested?
The trial is testing DS-3939a's safety and effectiveness on patients with advanced solid tumors. It will involve two parts: one for various cancer types without molecular subtype restrictions and another for those who've seen their cancer progress after recent treatment.See study design
What are the potential side effects?
While the exact side effects are not listed here due to this being a first-in-human study of DS-3939a, common side effects from similar trials may include fatigue, nausea, skin reactions at the injection site and potential immune-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 47 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 47 months
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 Dose-limiting Toxicities Following Treatment With DS-3939a
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)
Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
Secondary outcome measures
Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a
Disease Control Rate Following Treatment With DS-3939a
Duration of Response Following Treatment With DS-3939a
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part 2)Experimental Treatment1 Intervention
Multiple expansion cohorts targeting various advanced solid tumors.
Group II: Dose Escalation (Part 1)Experimental Treatment1 Intervention
Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.
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Who is running the clinical trial?
Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
415,871 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
419,728 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
162 Previous Clinical Trials
78,708 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have a lung condition not caused by an infection.I have or had cancer spread to my brain or spine.I have received treatments targeting MUC1 before.I have not had a stroke, mini-stroke, or blood clot in my arteries in the last 6 months.My heart pumps well, with an ejection fraction of 50% or higher.My organs are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I can provide a recent tumor sample for the study.I have had cancer before, but it was either skin cancer removed by surgery, cancer that was treated without spreading, or any cancer treated over 3 years ago with no signs of return.I have advanced cancer in the bladder, lung, breast, ovary, bile duct, or pancreas.My cancer is advanced, can't be surgically removed, and has worsened despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (Part 1)
- Group 2: Dose Expansion (Part 2)
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.
In how many distinct locales is this clinical study taking place?
"Currently, 6 clinical trial sites are recruiting patients for this medical research. Those locations include Charlotte, Providence and Salt Lake City as well as an additional three centres. To ease travel-related burdens on participants, it is suggested that they directly select the closest site to their residences upon enrolling in the study."
Answered by AI
Has the enrollment period for this clinical trial begun?
"As per the details found on clinicaltrials.gov, this study is not presently seeking recruits and was last updated on August 9th 2023. However, there are currently 2,637 other trials open to new participants."
Answered by AI
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