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Antibody-drug Conjugate
DS-8201a + Olaparib for Endometrial Cancer
Phase 1
Waitlist Available
Led By Jennifer L Veneris
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
Patients must have archival FFPE tissue available for central confirmation of HER2 testing
Dose Escalation and Dose Expansion Phases: Patients must have had at least one prior line of cytotoxic chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, DS-8201a and olaparib, in treating patients with HER2-expressing cancers. Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of deoxyribonucleic acid (DNA) damage. DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (
Who is the study for?
This trial is for adults with HER2-expressing cancers that are advanced or can't be surgically removed, and specifically includes those with endometrial cancer. Participants must have tried at least one chemotherapy before, have a good performance status, and meet certain health criteria like normal organ function tests. Pregnant women, patients with recent heart attacks or uncontrolled infections, and those on certain drugs are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of DS-8201a (an antibody-drug conjugate targeting HER2-positive tumor cells) and olaparib (a drug blocking enzymes involved in DNA repair), to see if they can shrink or stabilize these cancers. It's a phase I study to determine side effects and optimal dosages.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs due to the antibody component of DS-8201a; damage from blocked DNA repair mechanisms caused by olaparib; fatigue; blood disorders; increased risk of infection; as well as specific risks associated with each drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a preserved tissue sample for HER2 testing.
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I have had at least one round of chemotherapy before.
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I have a confirmed diagnosis of uterine serous carcinoma and at least one tumor that can be safely biopsied.
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My tumor is HER2-positive, confirmed by a certified lab.
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I have a preserved tissue sample available for HER2 testing.
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My hepatitis C is cured or currently undetectable.
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I agree to use effective birth control during and for 7 months after the study.
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I am a woman who cannot become pregnant due to surgery or menopause.
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I am 18 years old or older.
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I have received chemotherapy before.
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My hepatitis B virus load is undetectable with treatment.
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I am mostly able to care for myself and perform daily activities.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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My cancer can be measured or evaluated using specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose/recommended phase 2 dose
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Markers of deoxyribonucleic acid (DNA) damage response (DDR)
+2 moreOther outcome measures
Biomarkers of response and resistance
Changes in HER2 expression
Formation of TOP1cc in tumor specimens
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan, olaparib)Experimental Treatment6 Interventions
Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 and olaparib PO BID on days 1-21 or days 8-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients taking olaparib BID on days 1-21 undergo collection of blood samples at the following times: baseline, days 1, 2, 8, and 15 of cycle 1, day 1 of cycle 2, days 1, 8, and 15 of cycle 3, day 1 of cycle 4, day 1 of every fourth cycle after cycle 4 and then at treatment end. Patients taking olaparib BID on days 8-14 undergo collection of blood samples at the following times: baseline, days 1, 2, 8, 9, and 15 of cycle 1, days 1 and 8 of cycle 2, days 1, 8, and 15 of cycle 3, day 1 of cycle 4, day 1 of every fourth cycle after that, and at treatment end. Patients undergo biopsy at baseline, and then on day 3 or day 10 of cycle 1. Patients also undergo echocardiography and CT throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Trastuzumab Deruxtecan
2021
Completed Phase 3
~610
Olaparib
2007
Completed Phase 4
~2210
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,309 Total Patients Enrolled
Jennifer L VenerisPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
Elizabeth LeePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a preserved tissue sample for HER2 testing.I have had at least one round of chemotherapy before.I have a confirmed diagnosis of uterine serous carcinoma and at least one tumor that can be safely biopsied.You have experienced allergic reactions to similar drugs or compounds like DS-8201a, olaparib or monoclonal antibodies.My cancer has some level of HER2 expression or amplification.I haven't had any blood or platelet transfusions in the last week.My heart's pumping ability is normal, confirmed by a recent heart scan.I will not donate or use my own eggs for 7 months after the last study drug.My tumor is HER2-positive, confirmed by a certified lab.I have a preserved tissue sample available for HER2 testing.My kidney function tests are within the required range.My hepatitis C is cured or currently undetectable.I have another cancer type, but it won't affect this cancer treatment.I agree to use effective birth control during and for 7 months after the study.My heart condition is not severe and is classified better than class 2B.I have side effects from cancer treatment that haven't improved to mild or gone back to how they were before treatment.I have or had lung inflammation that needed steroids, or it can't be ruled out by scans.I agree not to donate or freeze sperm during and for 4 months after the study.I am a woman who cannot become pregnant due to surgery or menopause.I am HIV-positive, on stable treatment, with no recent severe infections.I am 18 years old or older.I haven't received G-CSF treatment in the last week.I haven't had a heart attack or severe heart failure in the last 6 months.I have severe lung problems due to other illnesses or autoimmune conditions.My cancer shows some level of HER2 protein or gene amplification.My brain metastases are stable, I'm not on steroids, and it's been 4 weeks since my last radiation.I have received chemotherapy before.I am participating in the initial phase of a trial where doses are increased.I have not had radiation therapy in the last 4 weeks.I have previously taken PARP inhibitors.I haven't taken chloroquine or hydroxychloroquine in the last 14 days.I had major surgery less than 4 weeks ago.I am participating in either the dose escalation or expansion phase of a trial.I have had multiple treatments for my condition, including chemotherapy and targeted therapy.I do not have an infection needing IV drugs.I haven't had chemotherapy in the last 4 weeks, with some exceptions.My hepatitis B virus load is undetectable with treatment.You are currently taking part in another study with experimental medication.I am mostly able to care for myself and perform daily activities.I am not taking any strong or moderate drugs that affect liver enzymes.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I have a type of uterine cancer that can be safely biopsied.My cancer can be measured or evaluated using specific criteria.I am in the dose expansion phase of treatment.I have not had any cancer except for non-melanoma skin cancer, in-situ disease, or other solid tumors that were completely removed or treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trastuzumab deruxtecan, olaparib)
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.
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