Clinical trial · Interventional
A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
NCT03913741CI-TRIAL-00059259innovaTV 206completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tisotumab vedotin | Drug | Tisotumab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental tisotumab vedotin
- description
- Open label, single arm trial where tisotumab vedotin will be administered
- interventionNames
- Drug: tisotumab vedotin
Primary outcomes (9)
- measure
- Dose Escalation and Dose Expansion: Incidence of drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs) by CTCAE v5.0 [Safety]
- timeFrame
- Throughout the trial - until 90 days after last dose of tisotumab vedotin
- measure
- Dose Escalation and Dose Expansion: Incidence of Dose Limiting Toxicities (DLTs), AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [Tolerability]
- timeFrame
- Throughout the trial - until 90 days after last dose of tisotumab vedotin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria (Main): * PART 1 ONLY: Subjects with locally advanced or metastatic solid tumors, who have experienced disease progression while on standard therapy or are intolerant of, or not eligible for, standard therapy. * PART 2 ONLY: Subjects with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible. Patients must not have received more than 2 prior systemic treatment regimens for recurrent or metastatic cervical disease. * Measurable disease according to RECIST v1.1 * Must be at least 20 years of age on the day of signing informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration * Women of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration * A man who is sexually active with a WOCBP and has not had a vasectomy must agree to use a barrier method of birth control (Part 1 only) * Must provide signed informed consent before any trial-related activity is carried out. Exclusion Criteria (Main): * PART 2 ONLY: Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. * Known past or current coagulation defects leading to an increased risk of bleeding. * Ongoing major bleeding. * Has an active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible
References
Publications (1)
- RESULTYonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer Sci. 2022 Aug;113(8):2788-2797. doi: 10.1111/cas.15443. Epub 2022 Jun 15. PMID 35633184