Cancer of the ovary, cervix, endometrium, bladder, prostate (castration-resistant prostate cancer [CRPC]), esophagus or lung (non-small cell lung cancer [NSCLC]) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10014742 Term: Endometrial neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, maligna
Conditions
Interventions
Product Name: HuMax®-TF-ADC
Product Code: IgG1-1015-011-1006
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: tisotumab vedotin
CAS Number: 1418731-10-1
Curre
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. • Age = 18 years. • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. • Life expectancy of at least three months. • A negative serum pregnancy test (if female and aged between 18-55 years old). Women who are pregnant or breast feeding are not to be included. • Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of HuMax®-TF-ADC. • Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: • Known past or current coagulation defects leading to increased risk of bleeding. • Ongoing major bleeding • A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval = 120 msec in left bundle branch block form) or an incomplete left bundle branch block. • Therapeutic anti-coagulative or long term anti-platelet treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To establish the tolerability of HuMax-TF-ADC dosed three times q4wk in a mixed population of patients with specified solid tumors;Secondary Objective: • To determine the MTD and RP2D of HuMax-TF-ADC dosed three times q4wk • To establish the PK profile of HuMax-TF-ADC dosed three times q4wk • To evaluate the anti-tumor activity of HuMax-TF-ADC dosed three times q4wk in a mixed population of patients with specified solid tumors ;Primary end point(s): AEs during the study: Incidences of AEs, SAEs, infusion-related AEs, CTCAE grade = 3 AEs and AEs related to trial drug.;Timepoint(s) of evaluation of this end point: During the entire study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety laboratory parameters (hematology, biochemistry, coagulation factors and flow cytometry) • Skin disorders • Bleeding events • Neuropathy • PK parameters (clearance, volume of distribution and AUC [AUC0-Clast and AUC0-8], Cmax, time of Cmax [Tmax], pre dose values, and half-life of HuMax-TF-ADC and free toxin [MMAE]) • Immunogenicity of HuMax-TF-ADC (human anti human antibodies) • Anti-tumor activity measured by tumor shrinkage (based on CT-scan evaluations), change in PSA and CA 125 • Objective Response (Complete Response [CR] or PR), Disease Control (CR, PR or stable disease [SD]), Progression Free Survival (PFS) and Duration of Response (DoR) Research Endpoints: • TF expression in tumor biopsies • Circulating TF • Circulating cell-free deoxyribonucleic acid (cfDNA) ;Timepoint(s) of evaluation of this end point: At the end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed. | — |
Countries
Belgium, Denmark, Hungary, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed