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

NCT03913741 | Completed Phase 1 DMC

• 2 other identifiers: GCT1015-06JapicCTI-194639
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Solid Tumor

Keywords

tisotumab vedotin; cervical cancer

Outcome Measures

Primary Outcomes (9)

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

  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]

  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

  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

  Up to approximately 42 days after initial dose of tisotumab vedotin

• Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC(0-t))

  Up to approximately 42 days after initial dose of tisotumab vedotin

• Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin : Rate at which the drug is removed from the body (CL)

  Up to approximately 42 days after initial dose of tisotumab vedotin

• Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Elimination half-life of the drug (T½)

  Up to approximately 42 days after initial dose of tisotumab vedotin

• Dose Escalation and Dose Expansion Pharmacokinetics of tisotumab vedotin: Time after dosing at which the maximum drug concentration was observed (Tmax)

  Up to approximately 42 days after initial dose of tisotumab vedotin

• Dose Escalation and Dose Expansion: Assess immunogenicity of tisotumab vedotin by measuring and assessing Anti-drug Antibody (ADA)

  Summarized by descriptive statistics by trial part and dose

  Throughout and at the end of trial (up to 90 days after last dose of tisotumab vedotin)

Secondary Outcomes (3)

• Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Objective Response Rate (ORR) (based on RECIST 1.1)

  Up to approximately 6 months after the first dose of tisotumab vedotin

• Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Duration of Response (DOR) (based on RECIST 1.1)

  Up to approximately 6 months after the first dose of tisotumab vedotin

• Dose Escalation and Dose Expansion: Evaluate antitumor activity of tisotumab vedotin by assessing Time to Response (TTR) (based on RECIST 1.1)

  Up to approximately 6 months after the first dose of tisotumab vedotin

Study Arms (1)

Experimental tisotumab vedotin

EXPERIMENTAL

Open label, single arm trial where tisotumab vedotin will be administered

Drug: tisotumab vedotin

Interventions

tisotumab vedotin DRUG

Tisotumab vedotin will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial

Experimental tisotumab vedotin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Genmab: lead
• Seagen Inc.: collaborator

Study Sites (8)

National Cancer Center Hosptial East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

NHO Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

NHO Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Chūōku, Tokyo-To, 104-0045, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo-To, 160-8582, Japan

Location

Related Publications (1)

• Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer Sci. 2022 Aug;113(8):2788-2797. doi: 10.1111/cas.15443. Epub 2022 Jun 15.

  PMID: 35633184 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tisotumab vedotin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Keiichi Fujiwara, Professor

  Saitama Medical University International Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group assignment

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 12, 2019
• Study Start: February 27, 2019
• Primary Completion: August 14, 2020
• Study Completion: October 30, 2021
• Last Updated: June 23, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)