To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies
NCT ID: NCT05866354
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2023-06-16
2023-11-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* How is the PK of tisotumab vedotin?
* How is the immunogenicity of tisotumab vedotin?
* How is the safety and tolerability of tisotumab vedotin?
* How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.
Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.
Blood samples for the assessment of tisotumab vedotin concentrations and antidrug antibody (ADA) will be drawn in accordance with the PK and ADA collection schedule. Three different PK analytes will be measured: 1) tisotumab vedotin (conjugated antibody only), 2) total antibody (ie, conjugated and unconjugated antibody), and 3) free MMAE. PK parameters to be estimated will include, but are not limited to, AUC, Cmax, time to maximum concentration (Tmax), apparent terminal half-life (t1/2), and trough concentration (Ctrough).
Safety and tolerability will be evaluated based on TEAEs, clinical safety assessments and clinical laboratory assessments. Ocular AEs are a known safety risk of tisotumab vedotin treatment. Therefore, the eye care plan will be implemented for all subjects enrolled in this trial.
Efficacy assessments will include confirmed ORR assessed by the investigator, primarily based on the enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans performed at protocol-specified time points. The RECIST v1.1 criteria will be used for response evaluation. After discontinuation of study treatment, tumor assessments may or may not be performed at the discretion of the investigator.
At the end of study (EOS), sponsor will ensure provision of continued tisotumab vedotin to subjects with clinical benefit defined as stable disease (SD) or better, until criteria of treatment discontinuation are met.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of solid tumors including cervical cancer.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Must sign an informed consent form (ICF) .
3. Must have recurrent or metastatic solid tumors and have failed on previous standard systemic therapy.
4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Has life expectancy of at least 3 months.
6. Must demonstrate acceptable screening laboratory values.
7. Female subjects must agree not to breastfeed or donate ova. A male subject who is sexually active with a female partner of reproductive potential and has not had a vasectomy must agree to use a barrier method of birth control (eg, condom with spermicide), and all men must also not donate sperm during the trial and for 6 months after receiving the last dose of tisotumab vedotin.
8. Any other toxicity caused by previous treatment should have recovered to ≤ CTCAE grade 1 or baseline level, except ≤ CTCAE grade 2 alopecia.
Exclusion Criteria
2. Has cardiovascular issues or risks:
3. Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \> 1 month prior to screening is allowed).
4. Ophthalmological: active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (eg, Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), and subjects with penetrating ocular transplants are ineligible. Cataracts alone is not an exclusion criterion.
5. Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
6. Peripheral neuropathy ≥ grade 2.
7. Any prior treatment with MMAE-derived drugs.
8. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.
9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rutie Yin, Dr
Role: PRINCIPAL_INVESTIGATOR
West China Second University Hospital
Guiling Li, Dr
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Bingzhong Zhang, Dr
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Qing Wen, Dr
Role: PRINCIPAL_INVESTIGATOR
Jinan Central Hospital
Meili Sun, Dr
Role: PRINCIPAL_INVESTIGATOR
Jinan Central Hospital
Jianhua Shi, Dr
Role: PRINCIPAL_INVESTIGATOR
Linyi Cancer Hospital
Dongqing Lv, Dr
Role: PRINCIPAL_INVESTIGATOR
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Tienan Yi, Dr
Role: PRINCIPAL_INVESTIGATOR
Xiangyang Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jinan Central Hospital
Jinan, Shangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZL-1309-002
Identifier Type: -
Identifier Source: org_study_id