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Enzyme Inhibitor
Ceralasertib + Trastuzumab Deruxtecan for Solid Tumors
Phase 1
Recruiting
Led By Kanwal P Raghav
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will find the best dose and safety of ceralasertib when given with trastuzumab deruxtecan to treat patients with solid tumors that have a change in the HER2 gene or protein.
Who is the study for?
Adults with advanced solid tumors expressing HER2, who've tried at least one chemotherapy, can join this trial. They must have a measurable tumor and be able to undergo biopsies. Key health requirements include proper liver and kidney function, controlled HIV if present, no severe heart issues or lung disease like ILD/pneumonitis, and not pregnant.Check my eligibility
What is being tested?
The DASH trial is testing the combination of two drugs: DS-8201a (trastuzumab deruxtecan) which targets HER2 cancer cells with attached chemo drug deruxtecan; and AZD6738 (ceralasertib), which may halt tumor growth by blocking certain enzymes. The study has two phases to determine safety and compare responses in colorectal/gastroesophageal cancers.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in organs or infusion-related symptoms. There might also be typical chemotherapy side effects like fatigue, nausea, blood cell count changes increasing infection risk, and potential heart or lung complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My disease cannot be removed by surgery and has spread.
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I have a tumor that can be measured on a CT scan.
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I have an advanced solid tumor, such as breast or colon cancer.
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I agree to a biopsy of my cancer that can be easily reached.
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My tumor is HER2-positive, confirmed by a certified lab.
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My heart pumps well, with an ejection fraction of 50% or higher.
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My cancer is confirmed to be advanced stomach, esophagus, or colorectal.
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I've had chemotherapy for advanced cancer but it didn't work or I couldn't tolerate it.
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I am not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differential pharmacodynamic (PD) profile of tumor tissue (DNA damage & repair) (Dose expansion phase)
Incidence of adverse events (Dose escalation phase)
Recommended phase 2 dose (Dose escalation phase)
Secondary outcome measures
Anti-tumor activity of DS-8201a plus (+) AZD6738
Best overall response
Disease control rate
+7 moreOther outcome measures
Association of HER2 expression level and HER2 gene copy number and ORR
Palladium
Association of TOP1 expression level and ORR
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan, ceralasertib)Experimental Treatment2 Interventions
Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 and ceralasertib PO BID on days 1-7. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: During the dose-expansion phase, the first 6 patients in each disease cohort (gastroesophageal cancer [cohort A] and colorectal cancer [cohort B]) receive only trastuzumab deruxtecan for the first cycle, followed by trastuzumab deruxtecan and ceralasertib together in subsequent cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,839 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Kanwal P RaghavPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
1 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.My kidney function, measured by creatinine clearance, is good.I have an advanced solid tumor, such as breast or colon cancer.You have had strong allergic reactions to the drug or its inactive parts in the past.Your hemoglobin level is at least 9.0 grams per deciliter within two weeks before joining the study.My disease cannot be removed by surgery and has spread.I have a tumor that can be measured on a CT scan.I have never been treated with an ATR inhibitor.I agree to use birth control during the study.Your white blood cell count is at least 1,500 per microliter.I cannot take pills by mouth or have stomach issues that affect medication absorption.I have an advanced solid tumor, such as breast or colon cancer.I haven't had a heart attack in the last 6 months and my heart functions well.I have spinal cord compression or active brain metastases.I have lung problems due to another illness.I agree to a biopsy of my cancer that can be easily reached.Your liver enzyme levels are not more than 5 times the normal limit.I do not have a history of lung inflammation needing steroids, current lung inflammation, and I don’t use e-cigarettes.I have not had a blood transfusion in the last 4 months.My tumor is HER2-positive, confirmed by a certified lab.I am not taking strong CYP3A inhibitors.My heart pumps well, with an ejection fraction of 50% or higher.Your white blood cell count is at least 3,000 cells per microliter within 14 days before the study.I am HIV positive and meet specific health criteria.I need treatment to remove fluid from my chest, abdomen, or around my heart.You have another medical condition that could make the treatment more dangerous, according to the doctor.Your albumin levels need to be higher than 2.5 g/dL if you have gastroesophageal junction cancer. This will be checked within 14 days before you join the study.I have taken corticosteroids within the last 2 weeks.I do not have any unmanaged ongoing illnesses.I am not taking chloroquine or hydroxychloroquine.My cancer is confirmed to be advanced stomach, esophagus, or colorectal.I have recovered from side effects of previous cancer treatments, except for hair loss.I have not had any cancer except for non-melanoma skin cancer, in situ disease, or other solid tumors treated with curative intent in the last 2 years.Your blood clotting time is within the normal range.I am at risk for issues with blood flow in my brain.I have high blood pressure that needs treatment.I have had a bone marrow or double umbilical cord blood transplant.I experience significant drops in blood pressure when standing.I've had chemotherapy for advanced cancer but it didn't work or I couldn't tolerate it.I am not pregnant.I have been diagnosed with MDS/AML or show signs of these conditions.Your bilirubin levels must not be too high, unless you have a condition called Gilbert's Syndrome or liver metastases.I have another cancer, but it won't affect this trial's treatment.Your platelet count is at least 100,000 per microliter within the past 14 days before joining the study.I have brain metastases, but they are not currently causing symptoms.I do not have an infection that needs IV treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trastuzumab deruxtecan, ceralasertib)
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.
How many locations are engaged in the execution of this trial?
"Currently, this clinical trial is available at 12 different sites, such as Creve Coeur, Saint Louis and Sacramento. To reduce the burden of travel on enrolled patients it would be beneficial to locate a site close by."
Answered by AI
To what extent is Trastuzumab Deruxtecan a secure treatment for patients?
"Due to the limited data surrounding Trastuzumab Deruxtecan's safety and efficacy, our assessment at Power scored it a 1 on a scale of one to three."
Answered by AI
Are any additional participants being admitted to this research endeavor?
"Affirmative. Clinicaltrials.gov documents that this clinical trial is still welcoming participants, as it was first uploaded on March 5th 2021 and the last update occurred on October 20th 2022. Presently, there are 12 different sites recruiting a total of 15 patients for the study."
Answered by AI
Does this research represent an innovative approach?
"The drug Trastuzumab Deruxtecan is the subject of 58 active trials in 510 cities and 45 countries, with the first conducted by AstraZeneca in 2014. This initial trial involved 330 patients, progressed through Phase 1 & 2 regulatory processes successfully, and has since been repeated 10 times over."
Answered by AI
What is the participation size of this medical experiment?
"Affirmative. Clinicaltrials.gov shows that this clinical research initiative, which was first launched on March 5th 2021, is currently accepting applications from participants. The study aims to recruit 15 individuals spread out across 12 different sites."
Answered by AI
What further corroboration exists for the effects of Trastuzumab Deruxtecan?
"Trastuzumab Deruxtecan was initially studied in 2014 at Research Site, with 10 clinical trials completed until now. As of today, 58 active studies are recruiting participants from Creve Coeur, Missouri and beyond."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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