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NCT04513665

ZW25 in Women With Endometrial Cancers

Completed Phase 2 Results posted Last updated 22 May 2025
What this trial tests

Phase 2 trial testing ZW25 in Endometrial Cancer in 16 participants. Completed in 8 March 2024.

Timeline
12 August 2020
Primary endpoint
8 March 2024
8 March 2024

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment16
Start date12 August 2020
Primary completion8 March 2024
Estimated completion8 March 2024
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Endometrial Cancer or Carcinosarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate/ORR of Participants Primary · </= 24 weeks from the start of treatment

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

GroupValue95% CI
Stage 11
Stage 115

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks from end of treatment, up to 48 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage 1
Serious: 2/16 (13%)
Deaths: 8/16
Stage 2
Serious: 0
Deaths: 0

Serious adverse events (1 terms)

ReactionSystemStage 1Stage 2
Abdominal PainGastrointestinal disorders
Other adverse events (64 terms — click to expand)

ReactionSystemStage 1Stage 2
DiarrheaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders
FatigueGeneral disorders
NauseaGastrointestinal disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
DyspneaRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
Infusion related reactionInjury, poisoning and procedural complications
Nasal congestionRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
Weight lossInvestigations
Abdominal painGastrointestinal disorders
AscitesGastrointestinal disorders
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
DysgeusiaNervous system disorders
DyspepsiaGastrointestinal disorders
FeverGeneral disorders
HypertensionVascular disorders
Muscle crampMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
PalpitationsCardiac disorders
Abdominal distensionGastrointestinal disorders
Allergic reactionImmune system disorders
AlopeciaSkin and subcutaneous tissue disorders
AnemiaBlood and lymphatic system disorders
Back painMusculoskeletal and connective tissue disorders
Blurred visionEye disorders
Catheter related infectionInfections and infestations
Colonic obstructionGastrointestinal disorders
Dry eyeEye disorders
Dry mouthGastrointestinal disorders
DysuriaRenal and urinary disorders
Edema limbsGeneral disorders
Eyebrow hair lossSkin and subcutaneous tissue disorders
FloatersEye disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
HeadacheNervous system disorders
HemorrhoidsGastrointestinal disorders

Most-reported serious reactions: Abdominal Pain.

Data from ClinicalTrials.gov NCT04513665 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Bispecific Antibodies: From Research to Clinical Application.
    Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
  2. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
    Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
  3. Recombinant immunotoxins development for HER2-based targeted cancer therapies.
    Mahmoudi R, Dianat-Moghadam H, Poorebrahim M, Siapoush S, et al · · 2021 · cited 15× · PMID 34488747 · DOI 10.1186/s12935-021-02182-6
  4. Bispecific Antibody Format and the Organization of Immunological Synapses in T Cell-Redirecting Strategies for Cancer Immunotherapy.
    Carrasco-Padilla C, Hernaiz-Esteban A, Álvarez-Vallina L, Aguilar-Sopeña O, et al · · 2022 · cited 13× · PMID 36678761 · DOI 10.3390/pharmaceutics15010132
  5. Human epidermal growth factor receptor 2 targeted therapy in endometrial cancer: Clinical and pathological perspectives.
    Saito A, Yoshida H, Nishikawa T, Yonemori K. · · 2021 · cited 13× · PMID 34733610 · DOI 10.5306/wjco.v12.i10.868
  6. A phase 2 trial of zanidatamab in HER2-overexpressed advanced endometrial carcinoma and carcinosarcoma (ZW25-IST-2).
    Lumish M, Chui MH, Zhou Q, Iasonos A, et al · · 2024 · cited 10× · PMID 38262242 · DOI 10.1016/j.ygyno.2023.12.028
  7. Diagnostic and therapeutic advances for HER2-expressing or amplified gynecologic cancers.
    Lee EK, Kolin DL, Matulonis UA, Erickson BK. · · 2025 · cited 3× · PMID 40117942 · DOI 10.1016/j.ygyno.2025.03.011
  8. Exploring Zanidatamab's efficacy across HER2-positive Malignancies: a narrative review.
    Kanwal W, Narjis K, Musani S, Nancy F, et al · · 2025 · cited 2× · PMID 40025472 · DOI 10.1186/s12885-025-13749-1

Verify or expand the search:

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04513665.

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