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Drug

Tisotumab vedotin

Approved · EMA
ClassTubulin inhibitorEmerging researchLate-stage development
RxNorm2571094ChEMBLCHEMBL4297841ATCL01FX23UNIIT41737F88A
2
Research papers
3
Active clinical trials
16
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Study Tisotumab Vedotin in Metastatic or Recurrent Squamous Cell Carcinoma of the Vulva

Clinical trial2026-06-29Results expected Q1 2029 · ClinicalTrials.gov

A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Clinical trial2026-05-27Results expected Q2 2028 · ClinicalTrials.gov

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Clinical trial2026-03-20Primary completion · ClinicalTrials.gov

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer

Clinical trial2026-03-19Terminated · ClinicalTrials.gov

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Clinical trial2026-02-24Results posted · ClinicalTrials.gov

Approval: Tivdak (EMA)

Regulatory2025-03-28EMA

Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.

Research2024-07-01The New England journal of medicine

An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

Clinical trial2023-11-02Completed · ClinicalTrials.gov

Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study.

Research2023-08-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer

Clinical trial2023-07-25Results posted · ClinicalTrials.gov

Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen

Clinical trial2023-05-06Results posted · ClinicalTrials.gov

First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

Clinical trial2021-12-29Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tisotumab vedotin
RxNorm CUI
2571094
ChEMBL ID
CHEMBL4297841
ATC codes
L01FX23
UNII
T41737F88A
Primary mechanism
Tubulin inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

16 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tubulin beta-4B chain
TUBB4B · P68371
INHIBITORTubulin inhibitor
Tubulin beta-1 chain
TUBB1 · Q9H4B7
INHIBITORTubulin inhibitor
Tubulin alpha-3C chain
TUBA3C · P0DPH7
INHIBITORTubulin inhibitor
Tubulin alpha-4A chain
TUBA4A · P68366
INHIBITORTubulin inhibitor
Tubulin beta-3 chain
TUBB3 · Q13509
INHIBITORTubulin inhibitor
Tubulin alpha-1A chain
TUBA1A · Q71U36
INHIBITORTubulin inhibitor
Tubulin beta-4A chain
TUBB4A · P04350
INHIBITORTubulin inhibitor
Tubulin beta-8 chain
TUBB8 · Q3ZCM7
INHIBITORTubulin inhibitor
Tubulin beta chain
TUBB · P07437
INHIBITORTubulin inhibitor
Tubulin alpha-1B chain
TUBA1B · P68363
INHIBITORTubulin inhibitor
Tubulin alpha-1C chain
TUBA1C · Q9BQE3
INHIBITORTubulin inhibitor
Tubulin alpha-3E chain
TUBA3E · Q6PEY2
INHIBITORTubulin inhibitor
Tubulin beta-2A chain
TUBB2A · Q13885
INHIBITORTubulin inhibitor
Tubulin beta-2B chain
TUBB2B · Q9BVA1
INHIBITORTubulin inhibitor
Tubulin beta-6 chain
TUBB6 · Q9BUF5
INHIBITORTubulin inhibitor
Tissue factor
F3 · P13726
BINDING AGENTCoagulation factor III binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-03-28
Latest approval
2025-03-28
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-03-28Approval
Approval: Tivdak (EMA)
Indication: Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see… Show full indication

Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2026
3
Active studies
1
Recruiting
2
Late-stage (III+)
8
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 12
Phase 11Phase 1 / 24Phase 25Phase 32

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

CompletedPH IIISeagen, a wholly owned subsidiary of Pfizern=5022026

An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

CompletedPH IZai Lab (Shanghai) Co., Ltd.n=192023

A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer

CompletedPH IISeagen Inc.n=1022022

Open Label Phase 2 Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen

CompletedPH IISeagen Inc.n=982022

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

CompletedPH I/IIGenmabn=232021

First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

CompletedPH I/IISeagen Inc.n=1952019

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20232024
Most influential

Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.

The New England journal of medicine · 2024 · 107 cites

Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 63 cites
Recent papers

Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.

The New England journal of medicine · 2024 · 107 cites

Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 63 cites
Major research themes7
Uterine Cervical Neoplasms2Anemia1Antibodies, Monoclonal, Humanized1Antineoplastic Combined Chemotherapy Protocols1Lung Neoplasms1Neoplasm Recurrence, Local1Oligopeptides1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • The New England journal of medicine1
Leading researchers
  • Banerjee S2
  • Cibula D2
  • Gennigens C2
  • Ghamande S2
  • Lorusso D2
  • Soumaoro I2
  • Van Nieuwenhuysen E2
  • Vergote I2
Leading institutions
free-text, unnormalised
  • Amsterdam University Medical Centers1
  • Augusta University1
  • Baskent University1
  • Beatson West of Scotland Cancer Centre1
  • Bulovka University Hospital1
  • Centre for Cancer and Organ Diseases1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Carboplatin

Studied across 4 of the same disease areas as Tisotumab vedotin in the shared literature.

4 shared diseases1 shared paper
Pembrolizumab

Studied across 4 of the same disease areas as Tisotumab vedotin in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.