DS-8201a + Olaparib for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byElizabeth Lee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

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.

Research Team

Elizabeth Lee

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

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)

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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.

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Treatment Details

Interventions

DS-8201a (Antibody-drug Conjugate)
Olaparib (PARP Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.