Advanced Solid malignancies and Cervical cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Tisotumab vedotin
INN of investigational material : tisotumab vedotin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 cervcial 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
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics -Evaluate the safety and tolerability of tisotumab vedotin -Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) -Assess pharmacokinetics (PK) and immunogenicity of tisotumab vedotin | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Evaluate antitumor activity of tisotumab vedotin | — |
Countries
Japan
Outcome results
None listed