tisotumab vedotin
Trade name: TIVDAK
mAbapprovedADC
Approved
Sep 20, 2021
Clinical trial activity
11 trials · 17 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
10
Phase 3
2
Phase 4
0
Earliest trial started Nov 1, 2013 (NCT02001623)
Timeline
2020s
- Jan 1, 2021
Seattle Genetics — Earliest Phase 3 Sponsor(trial)
- Sep 20, 2021
Seattle Genetics — Earliest FDA Approval
- Sep 20, 2021
Seattle Genetics — Marketing Organization
- Sep 20, 2021
Seattle Genetics — NDA Secondary Org
- Sep 20, 2021
Seattle Genetics — NDA Organization
Indications
Approved for
Studied for
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Colorectal Neoplasms · Phase 2
- Endometrial Neoplasms · Phase 2
- Esophageal Neoplasms · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Hamartoma · Phase 2
- Lung Neoplasms · Phase 1/Phase 2
- Neoplasms · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Prostatic Neoplasms · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 3
Mechanism of action
- Tissue factorBINDING AGENT
F3 binding agent
- Coagulation factor IIIBINDING AGENT
Coagulation factor III binding agent
- TubulinINHIBITOR
Tubulin inhibitor
Beta tubulin vinca binding domain
- Tubulin beta-4B chain (TUBB4B) ↗
- Tubulin beta-1 chain (TUBB1) ↗
- Tubulin alpha-3C chain (TUBA3C) ↗
- Tubulin alpha-4A chain (TUBA4A) ↗
- Tubulin beta-3 chain (TUBB3) ↗
- Tubulin alpha-1A chain (TUBA1A) ↗
- Tubulin beta-4A chain (TUBB4A) ↗
- Tubulin beta-8 chain (TUBB8) ↗
- Tubulin beta chain (TUBB) ↗
- Tubulin alpha-1B chain (TUBA1B) ↗
- Tubulin alpha-1C chain (TUBA1C) ↗
- Tubulin alpha-3E chain (TUBA3E) ↗
- Tubulin beta-2A chain (TUBB2A) ↗
- Tubulin beta-2B chain (TUBB2B) ↗
- Tubulin beta-6 chain (TUBB6) ↗
Approval history
- approvedPriority reviewAcceleratedSep 20, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
- Payload
- Monomethylauristatin E
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL4297841 ↗
Also known as
- tisotumab vedotin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06459180 | Phase 3 | Jul 24, 2024 | European Network for Gynaecological Oncological Trial, GOG Foundation, Inc., Merck |
| NCT05866354 | Phase 1 | Jun 16, 2023 | Central South University, Huazhong University of Science and Technology, Jinan University, Linyi Tumour Hospital, Sichuan University, Sun Yat-Sen University, Wenzhou Medical University, Zai Lab Pty. Ltd. |
| NCT04697628 | Phase 3 | Feb 22, 2021 | Genmab, Seattle Genetics |
| NCT03913741 | Phase 1/Phase 2 (Phase 2) | Mar 13, 2019 | Genmab, Saitama Medical University, Seattle Genetics |
| NCT03786081 | Phase 1/Phase 2 (Phase 2) | Feb 27, 2019 | European Network for Gynaecological Oncological Trial, Genmab, Gynecologic Oncology Group, Katholieke Universiteit Leuven, Merck, Seattle Genetics |
| NCT03657043 | Phase 2 | Dec 31, 2018 | Genmab, Seattle Genetics |
| NCT03485209 | Phase 2 | Jun 25, 2018 | Genmab, Seattle Genetics |
| NCT03438396 | Phase 2 | Jun 12, 2018 | European Network for Gynaecological Oncological Trial, Genmab, Gynecologic Oncology Group, Katholieke Universiteit Leuven, Seattle Genetics |
| NCT03245736 | Phase 2 | Aug 23, 2017 | Genmab |
| NCT02552121 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2015 | Genmab, Royal Marsden Hospital NHS Trust |
| NCT02001623 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2013 | Genmab, Royal Marsden Hospital NHS Trust |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Genmab | For profit | 9 | 6 | 2 | 2013 |
| Seattle Genetics | For profit | 6 | 3 | 2 | 2018 |
| European Network for Gynaecological Oncological Trial | Academic/Hospital | 3 | 0 | 2 | 2018 |
| Gynecologic Oncology Group | Academic/Hospital | 2 | 0 | 1 | 2018 |
| Katholieke Universiteit Leuven | Academic/Hospital | 2 | 0 | 1 | 2018 |
| Merck | For profit | 2 | 1 | 2 | 2019 |
| Royal Marsden Hospital NHS Trust | Academic/Hospital | 2 | 0 | 1 | 2013 |
| Central South University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| GOG Foundation, Inc. | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Huazhong University of Science and Technology | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Jinan University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Linyi Tumour Hospital | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Saitama Medical University | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Sichuan University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Wenzhou Medical University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Zai Lab Pty. Ltd. | For profit | 1 | 1 | 1 | 2023 |
17 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Seattle Genetics | For profit | MKTG | Sep 20, 2021 |
| Seattle Genetics | For profit | NDA2 | Sep 20, 2021 |
| Seattle Genetics | For profit | NDA | Sep 20, 2021 |