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Enzyme Inhibitor

Ceralasertib + Trastuzumab Deruxtecan for Solid Tumors

Phase 1
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
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 below
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.
My disease cannot be removed by surgery and has spread.
I have a tumor that can be measured on a CT scan.
I agree to use birth control during the study.
I have an advanced solid tumor, such as breast or colon cancer.
I agree to a biopsy of my cancer that can be easily reached.
My tumor is HER2-positive, confirmed by a certified lab.
My heart pumps well, with an ejection fraction of 50% or higher.
I am HIV positive and meet specific health criteria.
My cancer is confirmed to be advanced stomach, esophagus, or colorectal.
I've had chemotherapy for advanced cancer but it didn't work or I couldn't tolerate it.
I am not pregnant.
I have another cancer, but it won't affect this trial's treatment.
I have brain metastases, but they are not currently causing symptoms.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other outcome measures
Association of HER2 expression level and HER2 gene copy number and ORR
Association of TOP1 expression level and ORR
+2 more

Trial 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Trastuzumab Deruxtecan
Completed Phase 3

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,138 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

Ceralasertib (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04704661 — Phase 1
Breast Cancer Research Study Groups: Treatment (trastuzumab deruxtecan, ceralasertib)
Breast Cancer Clinical Trial 2023: Ceralasertib Highlights & Side Effects. Trial Name: NCT04704661 — Phase 1
Ceralasertib (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704661 — Phase 1

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?
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Mar 2026