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A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

NCT03913741CompletedPHASE1, PHASE2INTERVENTIONAL

Summary

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies

Key Facts

Lead Sponsor

Genmab

Enrollment

Start Date

2019-02-27

Completion Date

2020-08-14

Study Type

INTERVENTIONAL

Official Title

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Interventions

tisotumab vedotin

Conditions

Solid Tumor

Eligibility

Age Range

20 Years+

Sex

ALL

Inclusion Criteria (Main):

* 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 cervical 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 (Main):

* 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

Outcome Measures

Primary Outcomes

Dose Escalation and Dose Expansion: Incidence of drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs) by CTCAE v5.0 [Safety]

Time frame: Throughout the trial - until 90 days after last dose of tisotumab vedotin

Dose Escalation and Dose Expansion: Incidence of Dose Limiting Toxicities (DLTs), AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [Tolerability]

Time frame: Throughout the trial - until 90 days after last dose of tisotumab vedotin

Dose Escalation: maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of tisotumab vedotin

Time frame: Up to 21 days after the first dose of tisotumab vedotin (each cycle is 21 days)

Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Maximum concentration (Cmax) after dosing