Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02001623|
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovary Cancer Cervix Cancer Endometrium Cancer Bladder Cancer Prostate Cancer (CRPC) Esophagus Cancer Lung Cancer(NSCLC) Squamous Cell Carcinoma of the Head and Neck (SCCHN)||Drug: Tisotumab Vedotin (HuMax-TF-ADC)||Phase 1 Phase 2|
The study is conducted in two parts. The dose escalation portion of the trial subjects are enrolled into cohorts at increasing dose levels of HuMax-TF-ADC in 21 day treatment cycles.
In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of HuMax-TF-ADC as determined in Part 1
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Escalation phase for dose finding followed by expansion phase|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2, 2019|
|Actual Study Completion Date :||May 2, 2019|
Experimental: Tisotumab Vedotin (HuMax-TF-ADC)
All arms of the trial (borh in escalation and expansion phase) will be administered tisotumab vedotin (HuMax-TF-ADC)
Drug: Tisotumab Vedotin (HuMax-TF-ADC)
- Adverse events measured throughout the study from first treatment until end of trial. [ Time Frame: After first treatment cycle (3 weeks) and at end of trial (an expected average of 6 months) ]As this is a phase I trial the main objective is to assess the safety and tolerability of HuMax-TF-ADC throughout the treatment periods of the patients participating in the trial.
- PK profile of HuMax-TF-ADC after single and multiple infusions [ Time Frame: After first treatment cycle (3 weeks) and at end of trial (an expected average of 6 months) ]
- Anti-tumor activity of HuMax-TF-ADC; tumor size (RECIST), PSA and/or CA-125 [ Time Frame: At end of trial (an expected average of 6 months) ]Evaluate the anti-tumor activity of HuMax-TF-ADC in a mixed population of patients with specified solid tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001623
|Principal Investigator:||Johann de Bono, Professor||The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust|