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Monoclonal Antibodies
DS-1062a for Non-Small Cell Lung 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
Pathologically documented unresectable or metastatic HNSCC that was previously treated with 1-3 prior lines of therapy including platinum and ICI (in combination or sequential), in the advanced or metastatic setting
Has a pathologically documented unresectable advanced NSCLC disease not amenable to curative therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)
Awards & highlights
Study Summary
This trial is studying a new drug, DS-1062a, for safety and tolerability in people with NSCLC that has not been cured by other treatments. The trial will be in two parts, with the first part looking at dose escalation and the second part looking at additional solid tumors. The trial is expected to last approximately 6 years and will be conducted in the United States and Japan.
Who is the study for?
This trial is for adults with various advanced solid tumors, including non-small cell lung cancer and breast cancer, that have not responded to standard treatments. Participants must have measurable disease, adequate organ function, agree to use contraception if of childbearing potential, and be willing to provide tissue samples. They should not have had certain prior treatments or conditions that would exclude them from the study.Check my eligibility
What is being tested?
The trial is testing a new drug called Datopotamab Deruxtecan (Dato-DXd) in humans for the first time. It includes dose escalation to find the safest dose and expansion phases across different tumor types over approximately six years. A sub-study compares steroid versus non-steroid mouthwash in preventing oral mucositis in participants receiving Dato-DXd.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, blood disorders like low platelet count or anemia which could lead to bleeding or tiredness respectively; increased risk of infections due to immune system suppression; and possible inflammation of organs such as lungs leading to breathing difficulties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head/neck cancer can't be removed by surgery and was treated with 1-3 therapies including platinum and immunotherapy.
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My advanced lung cancer cannot be removed by surgery.
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My breast cancer is advanced, cannot be surgically removed, and lacks hormone and HER2 receptors.
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My small cell lung cancer is advanced and was treated with specific drugs but not topotecan or irinotecan.
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I have never been treated with TROP2-targeted therapy.
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My cancer in the stomach or esophagus is advanced and was treated before, but it's not HER2 positive.
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My condition worsened after standard treatments or no standard treatment exists for it.
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I am 18 years old or older.
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I have not been treated with specific advanced cancer drugs, except T-DXd for HR-positive HER2-low breast cancer.
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My pancreatic cancer is advanced and was treated with at least one therapy before.
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My esophageal cancer cannot be removed by surgery and has been treated before with platinum-based chemotherapy.
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My cancer is advanced, cannot be surgically removed, and I've had treatment including an immune checkpoint inhibitor.
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My colorectal cancer is advanced and didn't respond to standard treatments but hasn't worsened in 6 months after irinotecan therapy.
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My ovarian cancer cannot be surgically removed, has returned or worsened within 6 months after platinum-based treatment.
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My ovarian, fallopian tube, or peritoneal cancer has returned or worsened 6 months after platinum chemotherapy.
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My breast cancer is HER2-low, hormone receptor positive, and was treated with T-DXd.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My endometrial cancer has come back or worsened after treatment, including at least one drug treatment.
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My blood and organs are functioning well enough for treatment.
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My cervical cancer has returned or worsened after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stomatitis
Number of participants with adverse events (AEs)
Number of participants with dose-limiting toxicities
Secondary outcome measures
AUC during the dosing period (AUCtau)
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Maximum concentration (Cmax)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion - All ParticipantsExperimental Treatment3 Interventions
All participants enrolled in the dose expansion part
Group II: Dose Escalation - All ParticipantsExperimental Treatment1 Intervention
All participants enrolled in the dose escalation part
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
392 Previous Clinical Trials
410,475 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
414,407 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,604,392 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a break from previous treatments before starting this new treatment cycle.My head/neck cancer can't be removed by surgery and was treated with 1-3 therapies including platinum and immunotherapy.I do not have active symptoms from brain metastases or spinal cord compression.I still have side effects from past cancer treatments.I have or had lung inflammation not caused by infection, treated with steroids.Your heart's electrical activity, called QT interval, is longer than normal on your ECG test.You have an infection that needs strong medicine through a vein, or have HIV that is not well controlled. If you have HIV, it must be well controlled with low virus levels, a high CD4+ count, and no recent serious infections related to HIV. You need to be tested for HIV during the Screening Period if it's allowed by local rules or a research ethics committee.You have had a serious allergic reaction to DS-1062a or other similar medications in the past.My advanced lung cancer cannot be removed by surgery.My breast cancer is advanced, cannot be surgically removed, and lacks hormone and HER2 receptors.My small cell lung cancer is advanced and was treated with specific drugs but not topotecan or irinotecan.I had cancer before, but it was either skin cancer removed by surgery, treated without spreading, or any cancer treated over 3 years ago with no current signs.I haven't had a heart attack or unstable heart pain in the last 6 months.I do not have severe heart failure, uncontrolled heart rhythm problems, or very high blood pressure.I had mouth sores from treatment that didn't heal within 3 months.I am allergic to certain medications, including steroids or ingredients in mouthwash.I have never been treated with TROP2-targeted therapy.My breast cancer is advanced, not HER2, hormone receptor positive, and didn't respond to hormone therapy. I've had 1-3 chemo treatments.I have an active or uncontrolled hepatitis B or C infection.I have severe lung problems due to other lung diseases or conditions affecting my lungs.My cancer has spread to the lining of my brain and spinal cord.I am currently using oral or inhaled steroids for asthma, COPD, or another condition.My condition worsened after standard treatments or no standard treatment exists for it.I am 18 years old or older.My cancer is advanced, cannot be surgically removed, and I've had treatment including an immune checkpoint inhibitor.My colorectal cancer is advanced and didn't respond to standard treatments but hasn't worsened in 6 months after irinotecan therapy.My cancer in the stomach or esophagus is advanced and was treated before, but it's not HER2 positive.My heart pumps well, with an ejection fraction of 50% or higher.I have not been treated with specific advanced cancer drugs, except T-DXd for HR-positive HER2-low breast cancer.My pancreatic cancer is advanced and was treated with at least one therapy before.My esophageal cancer cannot be removed by surgery and has been treated before with platinum-based chemotherapy.My ovarian cancer cannot be surgically removed, has returned or worsened within 6 months after platinum-based treatment.My ovarian, fallopian tube, or peritoneal cancer has returned or worsened 6 months after platinum chemotherapy.My prostate cancer can't be removed, hasn't responded to specific treatments, and I haven't had chemotherapy.My breast cancer is HER2-low, hormone receptor positive, and was treated with T-DXd.I am willing to fill out a daily questionnaire about my mouth care and any mouth sores.I am fully active or restricted in physically strenuous activity but can do light work.You have a disease that can be measured using a specific medical guideline.My endometrial cancer has come back or worsened after treatment, including at least one drug treatment.I have mouth sores or infections, including thrush, right now.I agree to give tissue samples for cancer marker tests.My blood and organs are functioning well enough for treatment.I can understand and sign the consent forms for the study and its specific parts.You are expected to live for at least 3 more months.My cervical cancer has returned or worsened after treatment.I understand the risks and am willing to follow the study rules.I agree to a biopsy for my treatment if it's possible and safe, and to provide tissue samples for testing.I have a serious eye condition affecting my cornea.I need medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion - All Participants
- Group 2: Dose Escalation - All Participants
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 which areas is the research study being overseen?
"Patients may enrol in this medical trial at Memorial Sloan-Kettering Cancer Center, Johns Hopkins Sibley Memorial Hospital and University of California, Los Angeles as well as a further dozen sites."
Answered by AI
Is this experiment actively looking for participants?
"Affirmative. According to clinicaltrials.gov, the advertised medical trial is still accepting applicants and was initially posted on January 31st 2018 with an update occurring November 9th 2022. In total, 770 participants are needed from 12 different centres around the country."
Answered by AI
What is the greatest amount of persons participating in this experiment?
"To move forward with the trial, 770 participants must be identified who meet all necessary inclusion criteria. The two primary locations where enrolment is taking place are Memorial Sloan-Kettering Cancer Center in New york and Johns Hopkins Sibley Memorial Hospital in Washington D.C.."
Answered by AI
What is the ultimate goal of this medical experiment?
"The main measure of this 8 week study will be the number of adverse events (AEs) reported. Secondary endpoints include AUC to last observable concentration (AUClast), minimum observed concentration, and maximum drug concentration. All outcomes are assessed based on DS-1062a, total anti-TROP2 antibody, MAAA-1181a categories."
Answered by AI
Has the FDA formally sanctioned DS-1062a?
"Due to the preliminary nature of this Phase 1 clinical trial, we rate DS-1062a's safety a score of 1. There is limited evidence supporting both its efficacy and safety."
Answered by AI
What other research has been conducted concerning the use of DS-1062a?
"Research into the effects of DS-1062a was initiated in 2018 at Johns Hopkins University. There are presently 8 ongoing studies, with a significant amount of them being conducted from within New york City."
Answered by AI
Is this clinical trial an unprecedented approach to healthcare?
"Currently, 8 trials for DS-1062a are active across 140 cities in 28 countries. This drug was initially tested by Daiichi Sankyo Inc., involving 770 participants in 2018 and successfully passed the phase 1 approval process with 0 additional studies since then."
Answered by AI
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