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Tisotumab Vedotin

Phase 1

Solid Malignancies | Small molecule | Other |Zai Lab Limited|Last Updated: Nov 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05866354To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid MalignanciesPHASE1 COMPLETED 19 — — Jun 16, 2023Nov 2, 2023Nov 27, 20231 China
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Study Endpoints
Primary Endpoints
PK parameter AUC of tisotumab vedotin
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

To assess PK of tisotumab vedotin.PK parameters to be estimated will include area under the concentration-time curve (AUC).

PK parameter Cmax of tisotumab vedotin
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

To assess PK of tisotumab vedotin.PK parameters to be estimated will include maximum concentration (Cmax).

PK parameter Tmax of tisotumab vedotin
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

To assess PK of tisotumab vedotin.PK parameters to be estimated will include time to maximum concentration (Tmax).

PK parameter t 1/2 of tisotumab vedotin
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

To assess PK of tisotumab vedotin.PK parameters to be estimated will include apparent terminal half-life (t 1/2).

PK parameter C trough of tisotumab vedotin
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

To assess PK of tisotumab vedotin.PK parameters to be estimated will include trough concentration (C trough).

Secondary Endpoints
Immunogenicity of tisotumab vedotin.
At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
Treatment-emergent adverse events (TEAEs) of tisotumab vedotin.
Through study completion, an average of 1 year.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Tisotumab VedotinDRUGTisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of solid tumors including cervical cancer.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥18 years. 2. Must sign an informed consent form (ICF) . 3. Must have recurrent or metastatic solid tumors and have failed on previous standard systemic therapy. 4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Has life expectancy of at le...

Countries:China
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