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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 baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months
Awards & highlights
Study Summary
This trial will test if a new drug combo is safe & effective for advanced cancer patients.
Who is the study for?
Adults over 18 with advanced solid tumors, specifically HER2-expressing or mutated, who've had prior treatment without success. They must have measurable lesions and be in good health with proper organ function. Women of childbearing age need a negative pregnancy test and agree to birth control; men must also use birth control.Check my eligibility
What is being tested?
The trial is testing DS-1103a combined with T-DXd for safety and effectiveness against advanced solid tumors. Participants will receive this combination therapy to see how well it works compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system, infusion-related responses, fatigue, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk, heart problems due to cardiotoxicity, and possible lung issues such as pneumonitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 44 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 Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)
Number of Participants with Dose-limiting Toxicities Following DS-1103a Combination Therapy (Dose Escalation)
Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Following DS-1103a Combination Therapy (Dose Expansion)
Secondary outcome measures
Clinical Benefit Rate Following DS-1103a Combination Therapy (Dose Escalation and Dose Expansion)
Disease Control Rate Following DS-1103a Combination Therapy Assessed by Investigator (Dose Escalation) or Blinded Independent Central Review (Dose Expansion)
Duration of Response Following DS-1103a Combination Therapy (Dose Escalation and Dose Expansion)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion: DS-1103a + T-DXdExperimental Treatment2 Interventions
Participants with HER2-low expressing breast cancer who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd 5.4 mg/kg Q3W starting on Cycle 1 Day 1.
Group II: Dose Escalation: DS-1103a + T-DXdExperimental Treatment2 Interventions
Participants with HER2-expressing or HER2-mutant advanced metastatic solid tumors who will receive an intravenous (IV) infusion of DS-1103a (starting dose of 100 mg) every 3 weeks (Q3W) starting on Cycle 1 Day 1. Starting on Cycle 2 Day 1 and on Day 1 of each subsequent cycle, participants will also receive T-DXd Q3W at a dose of 5.4 mg/kg.
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Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
416,148 Total Patients Enrolled
25 Trials studying Breast Cancer
17,549 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,080 Total Patients Enrolled
27 Trials studying Breast Cancer
19,524 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,625 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,261 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant, breastfeeding, or planning to become pregnant.I have been treated with anti-CD47 or anti-SIRPα therapy before.I am currently taking long-term steroids or other drugs that weaken my immune system.I have not received a live vaccine in the last 30 days.I am a man who is sterile or my partner uses effective birth control.I had a heart attack less than 6 months ago.I have an infection that needs IV treatment.I haven't had a clot in my arteries in the last 6 months.I have had more than one type of cancer in the past 3 years.I still have side effects from past cancer treatments.I have a serious lung condition besides my cancer.My organs and bone marrow are functioning well.My cancer did not respond to treatments and is HER2 positive or mutated.I am 18 years old or older.My cancer has spread to my brain or spinal cord.I have had surgery to remove one entire lung.I have an active primary immunodeficiency or HIV.I will not freeze or donate sperm during the trial.My breast cancer is confirmed by a lab test and meets specific criteria.I have an ongoing or serious condition affecting my cornea.My cancer is HER2 positive and cannot be removed or has spread.I will not donate my eggs during the trial.I have a history of lung inflammation or scarring.I have previously been treated with a specific type of targeted cancer drug.I am not pregnant and agree to use effective birth control.I haven't had severe high blood pressure or irregular heartbeats in the last month.I have an autoimmune or inflammatory condition affecting my lungs.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation: DS-1103a + T-DXd
- Group 2: Dose Expansion: DS-1103a + T-DXd
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.
Is enrollment still available for this research project?
"Data published on clinicaltrials.gov reveals this research endeavour is not taking new patients at present. Initially posted on April 10th 2023, the study was last revised March 1st and has since stopped enrolling participants. Fortunately, there are 3918 other medical trials actively recruiting right now."
Answered by AI
Are there hazardous implications to administering the combination of DS-1103a and T-DXd in escalating doses?
"A relative lack of supporting evidence results in the safety rating for this Phase 1 trial, Dose Escalation: DS-1103a + T-DXd, being assessed as a 1 on our team's scale."
Answered by AI
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