NIPH Clinical Trials Search

Trial of safety and efficacy of tisotumab vedotin in Japanese subjects with advanced solid malignancies

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Advanced Solid malignancies and Cervical cancer
Date of first enrollment	27/02/2019
Target sample size	25
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Tisotumab vedotin INN of investigational material : tisotumab vedotin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Tisotumab vedotin at 1.5 or 2.0 mg/kg will be administered every 3 weeks as an IV infusion. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	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 Outcome	efficacy Evaluate antitumor activity of tisotumab vedotin

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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