ClinicalTrials.gg
CompletedNCT04513665Updated May 22, 2025Results posted

ZW25 in Women With Endometrial Cancers

A Phase 2 interventional study of ZW25 in Endometrial Cancer and Carcinosarcoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This study is being done to test the drug ZW25 and look at whether this drug is effective in women with HER2-overexpressed endometrial cancer or carcinosarcoma that has been treated in the past.

02

Conditions studied

  • Endometrial Cancer
  • Carcinosarcoma

Keywords

  • Endometrial Cancer
  • Carcinosarcoma
  • ZW25
  • 20-162
  • Memorial Sloan Kettering Cancer Center
03

In context

Endometrial Neoplasms

1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.

This study's enrollment of 16 is below the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must be enrolled or agree to consent to the companion genomic profiling study MSKCC IRB# 12-245 Part A. Results are not required prior to initiating treatment on protocol, unless patients do not have other test results by IHC or FISH confirming overexpression.
  • Patients must have recurrent or persistent HER2 overexpressing endometrial cancer or endometrial carcinosarcoma. HER2 overexpression is defined as 3+ by IHC or 2+ with gene amplification by FISH (HER2/CEP17 ratio ≥ 2) or HER2 amplified (fold change ≥ 2) on MSK IMPACT.
  • Histologic documentation of diagnosis of endometrial carcinoma or carcinosarcoma is required.
  • Age ≥ 18 years
  • Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma (including and/or adjuvant chemotherapy). Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen. Prior hormonal therapy will not count as a prior regimen. Prior treatment with trastuzumab is allowed.
  • (ECOG) performance status of 0 or 1.
  • ≥ 50% on baseline screening ECHO.
  • Resolution of adverse effects of recent surgery, radiotherapy, or chemotherapy to Grade ≤ 1 prior to first study treatment (with the exception of alopecia or clinically insignificant laboratory values).
  • Patients must have . Measurable disease is defined by (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each non-nodal lesion must be 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or 20 mm when measured by chest x-ray. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
  • No active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).
  • All patients must consent to mandatory pre-treatment and post-treatment core needle .
  • Patients must have adequate hematological, liver, cardiac and kidney function within 14 days prior to first treatment:

    1. (ANC) ≥ 1.5 x 10\^9/L (> 1500 per mm\^3)
    2. ≥ 100 X 109/L (>100,000 per mm\^3)
    3. ≥ 8.0 g/dL
    4. Serum ≤ 1.5 x institutional (ULN). (Unless Gilbert's Syndrome, for which Bilirubin ≤ 3 x institutional upper limit of normal (ULN), without concurrent liver disease) (SGOT)/ALT (SGPT) ≤ 3 x institutional upper limit of normal (ULN) unless liver are present, in which case it must be ≤ 5x ULN.
    5. Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN).
  • For patients of , agreement to use two effective forms of (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 12 weeks after the last ZW25 dose.
  • Agree to practice total abstinence when this is in line with the preferred and usual lifestyle of the subject.

    1. A woman is considered to be of childbearing potential unless 1 of the following applies: She is considered to be permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, tubal ligation, and bilateral oophorectomy.
    2. She is , defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.
    3. Female patients of childbearing potential must have a negative serum pregnancy test result less than 3 day prior to administration of the first dose of study treatment.

Patients or their legally authorized representative (LAR) must be willing and able to sign the form, and to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or lactating or women of (WCBP) not protected by highly-effective methods.
  • > Grade 1 peripheral neuropathy.
  • History of hemorrhagic or ischemic stroke within the prior six months.
  • History of Class II-IV heart failure, no serious arrhythmia.
  • History of MI or unstable angina within 6 months of study initiation.
  • Patients with a lifetime cumulative dose of anthracycline >300 mg/m2 or who have received anthracycline treatment within 90 days of the expected first dose of ZW25 are not eligible for treatment.
  • Prior to monoclonal antibodies.
  • Active or infection. Patients with previously resolved hepatitis B infection are eligible. Presence of positive test results for hepatitis B infection who have resolved the infection (defined by positive for HB surface antibody (anti-HBs) and polymerase chain reaction (PCR) assay is negative for HBV DNA are eligible. Patients positive for HCV antibody are eligible only if testing for HCV RNA is negative.
  • Known infection.
  • Current severe, uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic disease).
  • Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment.
  • Known untreated or active central nervous system (CNS) (progressing or requiring anticonvulsants or for symptomatic control) .

Patients with a history of treated are eligible, provided that they meet all of the following criteria:

  1. Presence of outside the CNS
  2. No radiographic evidence of worsening upon the completion of CNSdirected therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
  3. No history of intracranial hemorrhage or spinal cord hemorrhage
  4. No ongoing requirement for dexamethasone as therapy for CNS disease (anticonvulsants at a stable dose are allowed)
  5. Absence of leptomeningeal disease

    • Inability to comply with study and follow-up procedures.
    • Known allergy or hypersensitivity to the components of ZW25 formulation.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    • Active or history of inflammatory bowel disease (IBD)
    • Severe infections within 4 weeks prior to initiation of study drug treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or to prevent exacerbation) are eligible for the study. Patients receiving antibiotic treatment for urinary tract infection are also eligible.
    • Administration of a within 4 weeks prior to initiation of study treatment or anticipated need for such a vaccine during study. Patients must agree not to receive live, attenuated influenza vaccine (e.g., Flumist®) within 4 weeks prior to treatment.)
    • Participation in another clinical study with receipt of an investigational product during the last 4 weeks.
    • History of another primary except for:

a. Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study drug and of low potential risk for recurrence. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ). d. Adequately treated stage 1 breast cancer.

  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) \< 21 days prior to the first dose of study drug. Receipt of the last dose of hormonal therapy within \< 7 days prior to the first dose of study drug.
  • Any prior radiation therapy must be discontinued at least four weeks prior to registration.
  • corrected for heart rate (QTc) ≥ 470 ms on screening (ECG) using QTC Federica.
  • History of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom free for more than 3 months.
  • Subjects with ascites, defined as ascites needing drainage catheter or therapeutic paracentesis more often than every 4 weeks.
  • Ongoing bowel perforation or presence of bowel fistula or abscess within 3 months of registration.
Terms in these criteria, in plain language(34)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Stage 1

    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.

    Drug: ZW25

  • Experimental
    Stage 2

    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.

    Drug: ZW25

Interventions

  • DrugZW25

    ZW25 at 20mg/kg intravenously (IV) every two weeks.

06

What researchers measure

Primary outcomes

  1. Overall Response Rate/ORR of Participants

    ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment

    Time frame: </= 24 weeks from the start of treatment

07

Results

Posted Oct 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneStage 1Stage 2
Started160
Completed00
Not completed160
Withdrew: Adverse event20
Withdrew: Lack of efficacy140

Outcome measures

PrimaryOverall Response Rate/ORR of Participants

ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment

Time frame:
</= 24 weeks from the start of treatment
Reported as:
Count of participants · Participants
Overall Response Rate/ORR of Participants
ParticipantsStage 1Stage 2
Participants with ORR (CR + PR)1—
Participants without ORR (CR + PR)15—

Adverse events

Collected over 24 weeks from end of treatment, up to 48 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stage 18/16 (50%)2/16 (12.5%)16/16 (100%)
Stage 2———
Most frequent serious events
Most frequent serious events
EventStage 1Stage 2
Abdominal PainGastrointestinal disorders2/16—
Most frequent other events
Showing 10 of 64
Most frequent other events
EventStage 1Stage 2
DiarrheaGastrointestinal disorders12/16—
AnorexiaMetabolism and nutrition disorders7/16—
MyalgiaMusculoskeletal and connective tissue disorders5/16—
FatigueGeneral disorders4/16—
NauseaGastrointestinal disorders4/16—
Rash maculo-papularSkin and subcutaneous tissue disorders4/16—
DyspneaRespiratory, thoracic and mediastinal disorders3/16—
FallInjury, poisoning and procedural complications3/16—
Infusion related reactionInjury, poisoning and procedural complications3/16—
Nasal congestionRespiratory, thoracic and mediastinal disorders3/16—

Baseline characteristics

No participants accrued to Stage 2

Age, Continuous
Age, Continuous(years)Stage 1Stage 2Total
Median71 (64 to 86)—71 (64 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Stage 1Stage 2Total
Female16—16
Male0—0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Stage 1Stage 2Total
Hispanic or Latino0—0
Not Hispanic or Latino16—16
Unknown or Not Reported0—0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Stage 1Stage 2Total
American Indian or Alaska Native0—0
Asian1—1
Native Hawaiian or Other Pacific Islander0—0
Black or African American5—5
White10—10
More than one race0—0
Unknown or Not Reported0—0
Region of Enrollment
Region of Enrollment(Participants)Stage 1Stage 2Total
United States16—16
08

Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen (Limited protocol activities)
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Limited protocol activities)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau (Limited protocol activities)
    Rockville Centre, New York 11570, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Mar 2024, 42 months.

Results were first posted in Oct 2024, 7 months after primary completion.

Of 107 non-industry phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 115. This study's 42 months is below that.

Counting every sponsor, half of 139 studies reached it within 55 months; a quarter within 37 and three quarters within 115.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2020
First posted
Aug 14, 2020
StartActual
Aug 12, 2020
Primary completionActual
Mar 8, 2024
CompletionActual
Mar 8, 2024
Results first posted
Oct 21, 2024
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04513665
Collaborators
Zymeworks BC Inc.
Responsible party
Sponsor
First posted
Aug 14, 2020
Start date
Aug 12, 2020
Primary completion
Mar 8, 2024
Completion
Mar 8, 2024
Results posted
Oct 21, 2024
Last update
May 22, 2025

Study contacts

Vikky Makker, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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