Asset profile

Disitamab Vedotin

Antibody–drug conjugate

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Phase 3underway

Evidence outlook · registrational

HR+/HER2- Metastatic Breast Cancer: registrational readout pending

Entered Phase 3 on weak signal mid-stage evidence. Registrational readout expected around 2027-12-31.

NCT03052634: The study was non-randomized, open-label, and had no comparator arm; all participants received disitamab vedotin at one of several doses. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

Also in development:Non-Small Cell Lung Cancer · Phase 2

How the evidence outlook works ↗

Competitive landscape

129 competitors in this universe: 13 direct rivals (same mechanism and indication), 0 same-class, 116 same-indication; 83 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Disitamab Vedotin: this drugPhase 3Antibody–drug conjugateHER2
Trastuzumab DeruxtecanApprovedAntibody–drug conjugateHER2
ZanidatamabApprovedMultispecific antibodyHER2
ZongertinibApprovedSmall moleculeHER2, HER2 Mutant-selective
BL-M07D1Phase 3Antibody–drug conjugateHER2
DB-1303Phase 3Monoclonal antibodyHER2
Trastuzumab RezetecanPhase 3Antibody–drug conjugateHER2
TucatinibPhase 3Small moleculeHER2
HRS-4508Phase 2Small moleculeHER2
177Lu-DWJ155Phase 1RadiopharmaceuticalHER2
BL-M17D1Phase 1Antibody–drug conjugateHER2
KJ015Phase 1Monoclonal antibodyHER2
MT-304Phase 1Cell therapyHER2
NVL-330Phase 1Small moleculeHER2
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4

…and 114 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(56 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (7)
December 2026 (7)
Phase 2/3Gastric Cancer, Gastroesophageal Junction AdenocarcinomaRecruiting
Est. primary completion 2026-12 · NCT06221748 · CT.gov ↗
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Early phase / not applicableHR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12 · NCT05831878 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12-06 · NCT07446452 · CT.gov ↗
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Phase 2Urothelial CarcinomaRecruiting
Est. primary completion 2026-12-11 · NCT04879329 · CT.gov ↗
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Phase 2mCRPCRecruiting
Est. primary completion 2026-12-30 · NCT07093866 · CT.gov ↗
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Phase 2HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric CarcinomaRecruiting
Est. primary completion 2026-12-31 · NCT06730373 · CT.gov ↗
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Phase 3Urothelial Carcinoma, HER2-expressingRecruiting
Est. primary completion 2026-12-31 · NCT05302284 · CT.gov ↗
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2027 (26)
January 2027 (5)
Phase 2Paget Disease, Extramammary, Scrotum DiseaseRecruiting
Est. primary completion 2027-01 · NCT06791070 · CT.gov ↗
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Phase 2Advanced Urothelial Carcinoma, Probiotics, ImmunotherapyRecruiting
Est. primary completion 2027-01-01 · NCT06904573 · CT.gov ↗
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Phase 2Ovarian Cancer, HER2Recruiting
Est. primary completion 2027-01-04 · NCT07285941 · CT.gov ↗
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Phase 3Urothelial CarcinomaActive not recruiting
Est. primary completion 2027-01-29 · NCT05911295 · CT.gov ↗
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Phase 2Upper Urinary Tract Urothelial CarcinomaNot yet recruiting
Est. primary completion 2027-01-31 · NCT07591805 · CT.gov ↗
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February 2027 (1)
Phase 2Recurrent Cervical CancerNot yet recruiting
Est. primary completion 2027-02-28 · NCT07172217 · CT.gov ↗
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April 2027 (1)
Phase 2Non-Muscle-Invasive Bladder Cancer (NMIBC)Recruiting
Est. primary completion 2027-04 · NCT07646145 · CT.gov ↗
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May 2027 (4)
Phase 2Gastric Cancer/Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2027-05-01 · NCT06385873 · CT.gov ↗
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Phase 2Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal CarcinomaRecruiting
Est. primary completion 2027-05-17 · NCT06420973 · CT.gov ↗
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Phase 1/2Prostate Cancer, CDK12 Gene MutationRecruiting
Est. primary completion 2027-05-31 · NCT06663007 · CT.gov ↗
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Phase 2Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib, Immune Checkpoint InhibitorsNot yet recruiting
Est. primary completion 2027-05-31 · NCT07159217 · CT.gov ↗
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June 2027 (2)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-06-22 · NCT06734182 · CT.gov ↗
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Phase 2Cervical CancerRecruiting
Est. primary completion 2027-06-30 · NCT06155396 · CT.gov ↗
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August 2027 (2)
Phase 2Urothelial Carcinoma of the Renal Pelvis and Ureter, Neoadjuvant TherapyNot yet recruiting
Est. primary completion 2027-08-01 · NCT07720921 · CT.gov ↗
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Phase 2UrologyNot yet recruiting
Est. primary completion 2027-08-30 · NCT07151560 · CT.gov ↗
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September 2027 (1)
Phase 2Gastric Cancer, Gastroesophageal Junction AdenocarcinomaRecruiting
Est. primary completion 2027-09-01 · NCT06560528 · CT.gov ↗
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October 2027 (2)
Phase 2Sebaceous Gland CarcinomaNot yet recruiting
Est. primary completion 2027-10-01 · NCT07740993 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-10-25 · NCT06966453 · CT.gov ↗
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December 2027 (8)
Phase 2Carcinoma, Upper Tract Urothelial Carcinoma, UTUCRecruiting
Est. primary completion 2027-12 · NCT05917158 · CT.gov ↗
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Phase 1/2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2027-12-01 · NCT05745740 · CT.gov ↗
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Phase 2Muscle-invasive Bladder Urothelial CarcinomaNot yet recruiting
Est. primary completion 2027-12-10 · NCT07279597 · CT.gov ↗
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Phase 2Extramammary Paget Disease, Scrotum DiseaseRecruiting
Est. primary completion 2027-12-30 · NCT07117851 · CT.gov ↗
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Phase 2Ovarian Cancer Metastatic, Ovarian Cancer Metastatic RecurrentRecruiting
Est. primary completion 2027-12-30 · NCT07311577 · CT.gov ↗
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Phase 2Muscle Invasive Bladder Cancer (MIBC)Not yet recruiting
Est. primary completion 2027-12-30 · NCT07201675 · CT.gov ↗
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Phase 2Upper Tract Urothelial CarcinomaNot yet recruiting
Est. primary completion 2027-12-31 · NCT07584733 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT04400695 · CT.gov ↗
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2028 (13)
January 2028 (1)
Phase 2/3HER2-positive Breast Cancer, Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-01-16 · NCT07366840 · CT.gov ↗
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March 2028 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-03-01 · NCT05904964 · CT.gov ↗
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April 2028 (1)
Phase 2Gastric AdenocarcinomaNot yet recruiting
Est. primary completion 2028-04-30 · NCT07507526 · CT.gov ↗
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May 2028 (3)
Phase 3Gastric CarcinomaNot yet recruiting
Est. primary completion 2028-05-15 · NCT06944496 · CT.gov ↗
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Phase 2Upper Urinary Tract Urothelial CarcinomaRecruiting
Est. primary completion 2028-05-31 · NCT06210490 · CT.gov ↗
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Phase 2HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBTNot yet recruiting
Est. primary completion 2028-05-31 · NCT07100184 · CT.gov ↗
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June 2028 (2)
Phase 2HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2028-06 · NCT07490990 · CT.gov ↗
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Phase 2Bladder Urothelial Carcinoma, Bladder CancerRecruiting
Est. primary completion 2028-06-30 · NCT07717242 · CT.gov ↗
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July 2028 (2)
Phase 3MIBCRecruiting
Est. primary completion 2028-07-01 · NCT07693959 · CT.gov ↗
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Phase 2Salivary Gland Carcinoma, Precision TherapyRecruiting
Est. primary completion 2028-07-10 · NCT06145308 · CT.gov ↗
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August 2028 (1)
Phase 2Ovary CancerRecruiting
Est. primary completion 2028-08-01 · NCT06540729 · CT.gov ↗
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September 2028 (1)
Phase 2Gastric CancerRecruiting
Est. primary completion 2028-09-30 · NCT07194005 · CT.gov ↗
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December 2028 (1)
Phase 2GC/GEJCRecruiting
Est. primary completion 2028-12-31 · NCT07474324 · CT.gov ↗
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2029 (6)
March 2029 (1)
Phase 1/2High-risk Non-muscle Invasive Bladder CancerRecruiting
Est. primary completion 2029-03-15 · NCT06378242 · CT.gov ↗
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April 2029 (1)
Phase 2Rectal CancerNot yet recruiting
Est. primary completion 2029-04-10 · NCT07509424 · CT.gov ↗
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May 2029 (1)
Phase 3Upper Tract Urothelial CarcinomaRecruiting
Est. primary completion 2029-05-01 · NCT07498907 · CT.gov ↗
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June 2029 (2)
Phase 2/3Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder CancerNot yet recruiting
Est. primary completion 2029-06-20 · NCT07756008 · CT.gov ↗
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Phase 3Gastric CarcinomaRecruiting
Est. primary completion 2029-06-30 · NCT07315750 · CT.gov ↗
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July 2029 (1)
Phase 2Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms, Stomach Neoplasms …Active not recruiting
Est. primary completion 2029-07-28 · NCT06157892 · CT.gov ↗
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2030 (1)
June 2030 (1)
Phase 2/3Urinary Bladder NeoplasmsNot yet recruiting
Est. primary completion 2030-06-30 · NCT07608224 · CT.gov ↗
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2031 (3)
March 2031 (1)
Phase 2Muscle Invasive Bladder Cancer (MIBC)Not yet recruiting
Est. primary completion 2031-03-31 · NCT07474064 · CT.gov ↗
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June 2031 (1)
Phase 3HER2-positive Metastatic Breast Cancer, First-line TreatmentRecruiting
Est. primary completion 2031-06-30 · NCT06278870 · CT.gov ↗
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December 2031 (1)
Phase 1/2Advanced Solid TumorsRecruiting
Est. primary completion 2031-12-31 · NCT06417554 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (10)
Phase 2/3 (6)
Phase 2 (96)
Phase 1/2 (16)
Phase 1 (7)
Phase 4 (4)
Early phase / not applicable (4)
Appears in other studies (5)