55 Participants Needed

DS-8201a + Olaparib for Endometrial Cancer

Recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and best dose of two drugs, DS-8201a and olaparib, in patients with certain advanced cancers. DS-8201a targets and kills cancer cells with a specific protein, and olaparib stops cancer cells from fixing their DNA. The goal is to see if these drugs can shrink or control the cancer.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take medications that are moderate or strong inhibitors or inducers of CYP3A, and if you are taking chloroquine or hydroxychloroquine, you will need a 14-day washout period (time without taking these medications) before joining the study.

Is the combination of DS-8201a and Olaparib safe for humans?

Olaparib (also known as Lynparza) has been studied for safety in various cancers, including ovarian and breast cancer. It is generally considered safe, but like all medications, it can have side effects, which may include nausea, fatigue, and anemia (low red blood cell count). There is limited specific safety data available for the combination of DS-8201a and Olaparib in endometrial cancer.12345

What makes the drug combination of DS-8201a and Olaparib unique for treating endometrial cancer?

The combination of DS-8201a and Olaparib is unique because it pairs a novel antibody-drug conjugate (DS-8201a) with a PARP inhibitor (Olaparib), which is known for its effectiveness in treating cancers with DNA repair deficiencies, like BRCA mutations. This approach targets cancer cells more precisely and may offer a new treatment option for endometrial cancer, which currently lacks many targeted therapies.15678

What data supports the effectiveness of the drug Olaparib for treating endometrial cancer?

Olaparib has shown promising results in treating ovarian cancer, particularly in patients with BRCA mutations, and is approved for use in certain types of breast cancer. This suggests it may have potential benefits for other cancers, like endometrial cancer, that share similar genetic characteristics.12369

Who Is on the Research Team?

EL

Elizabeth Lee

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a preserved tissue sample for HER2 testing.
AST/ALT =< 3 x institutional ULN (within 14 days of randomization/enrollment)
INR/PT and aPTT =< 1.5 x ULN (within 14 days of randomization/enrollment)
See 36 more

Exclusion Criteria

You have experienced allergic reactions to similar drugs or compounds like DS-8201a, olaparib or monoclonal antibodies.
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.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trastuzumab deruxtecan IV and olaparib PO in cycles of 21 days, with blood samples, ECHO or MUGA, and CT scans conducted throughout the trial

Up to 42 days
Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • DS-8201a
  • Olaparib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan, olaparib)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Olaparib is a powerful inhibitor of PARP-1 and PARP-2, showing effectiveness in treating ovarian cancer, particularly in patients with germline BRCA mutations.
Phase III trials are currently evaluating olaparib's efficacy as a maintenance therapy after initial treatment in patients with BRCA mutations, highlighting its potential role in long-term cancer management.
Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer.Gunderson, CC., Moore, KN.[2016]
Olaparib (Lynparza) is approved for treating adult patients with high-risk early breast cancer that has a germline BRCA mutation, following chemotherapy treatment.
This approval highlights Olaparib's role as an adjuvant therapy, which means it is used after initial treatments to help prevent cancer recurrence.
New Adjuvant Treatment for High-Risk Early Breast Cancer.Aschenbrenner, DS.[2022]
The OPINION study is evaluating the safety and efficacy of olaparib as a maintenance therapy for women with high-grade serous or endometrioid platinum-sensitive relapsed ovarian cancer who do not have BRCA mutations, involving patients who have undergone at least two prior lines of platinum-based chemotherapy.
The primary goal of the study is to assess progression-free survival, which will help determine how effective olaparib is in delaying cancer progression in this specific patient population.
Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design.Poveda, AM., Davidson, R., Blakeley, C., et al.[2020]

Citations

Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. [2016]
New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]
Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design. [2020]
Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. [2022]
Safety evaluation of olaparib for treating ovarian cancer. [2015]
Complete Pathologic Response to PARP Inhibitor Olaparib in a Patient with Stage IVB Recurrent Endometrioid Endometrial Adenocarcinoma. [2023]
Olaparib: first global approval. [2020]
Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes. [2020]
Olaparib: a review of its use as maintenance therapy in patients with ovarian cancer. [2016]
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