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Monoclonal Antibodies
ZW25 for Endometrial Cancer
Phase 2
Waitlist Available
Led By Vikky Makker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up </= 24 weeks from the start of treatment
Awards & highlights
Study Summary
This trial is looking at whether ZW25 is effective for treating HER2-overexpressed endometrial cancer or carcinosarcoma in women who have been treated in the past.
Who is the study for?
This trial is for women aged 18 or older with HER2-overexpressing endometrial cancer or carcinosarcoma that has been treated before. They should have had one to two prior chemotherapy treatments, be in good physical condition (ECOG status of 0 or 1), and have a heart function test (LVEF) showing ≥50%. Participants must not be pregnant, agree to use contraception, and can't have certain health conditions like active infections requiring antibiotics.Check my eligibility
What is being tested?
The study tests ZW25's effectiveness on women with specific types of endometrial cancers that express too much of a protein called HER2. These participants will already have undergone some treatment previously. The drug's impact on the size and spread of their tumors will be measured using standard criteria.See study design
What are the potential side effects?
While the exact side effects are not listed here, similar drugs often cause reactions at the infusion site, flu-like symptoms, nausea, diarrhea, rashes or allergic reactions. There may also be an increased risk of infection due to changes in blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ </= 24 weeks from the start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~</= 24 weeks from the start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate/ORR of participants
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 2Experimental Treatment1 Intervention
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
Group II: Stage 1Experimental Treatment1 Intervention
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZW25
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Zymeworks BC Inc.Industry Sponsor
3 Previous Clinical Trials
994 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,605 Total Patients Enrolled
5 Trials studying Carcinosarcoma
204 Patients Enrolled for Carcinosarcoma
Zymeworks Inc.Industry Sponsor
10 Previous Clinical Trials
2,292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had inflammatory bowel disease.My endometrial cancer is HER2 positive.I stopped any radiation therapy at least 4 weeks ago.I am not pregnant, breastfeeding, and if I can bear children, I use effective birth control.I do not have severe numbness or pain in my hands or feet.I have not had a heart attack or unstable chest pain in the last 6 months.I do not have any severe illnesses that are not under control.I am HIV positive.I had hepatitis B but it's resolved, or I have hepatitis C but no active virus.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.I have had cancer before, but it meets the trial's exceptions.I have had a blockage in my intestines within the last 3 months.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had any severe infections or been hospitalized for them in the last 4 weeks.I have had 1 or 2 chemotherapy treatments for endometrial cancer.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I do not have untreated brain metastases needing medication for symptoms.I have at least one tumor that can be clearly measured.I have not had a bowel perforation, fistula, or abscess in the last 3 months.I have heart failure but no serious irregular heartbeats.I received my last cancer treatment less than 3 weeks ago.My blood, liver, heart, and kidney functions are all within normal ranges.I do not have any infections needing antibiotics, except maybe a simple UTI.I have had a stroke in the last six months.My side effects from recent cancer treatment are mild or gone, except for hair loss.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have not had high doses of anthracycline or any in the last 3 months.I need frequent procedures to remove excess fluid from my abdomen.My diagnosis of endometrial cancer or carcinosarcoma is confirmed by tissue analysis.I agree to abstain from sexual activity if it aligns with my usual lifestyle.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1
- Group 2: Stage 2
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 participants is the team seeking to include in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting patients having been initially posted on 12th August 2020 and last updated 11th January 2022. 25 participants are needed from 7 healthcare facilities in total."
Answered by AI
Has the Food and Drug Administration sanctioned ZW25?
"Even though the efficacy of ZW25 has yet to be established, there is enough evidence that confirms its safety to rate it a 2 on our scale."
Answered by AI
Are there any vacancies for participants at this research trial?
"Affirmative. According to clinicaltrials.gov, the trial which was initially posted on August 12th 2020 is currently recruiting participants for a study involving 25 patients located at 7 distinct sites."
Answered by AI
In what geographic locations is this research endeavor taking place?
"Currently, seven medical centres are actively recruiting for this trial - including Memorial Sloan Kettering Nassau (limited protocol activities) in Rockville Centre and Memoral Sloan Kettering Westchester (limited protocol activities) in Harrison. Additionally, there are four other locations also participating."
Answered by AI
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