To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

NCT05866354 | Completed Phase 1

• 1 other identifier: ZL-1309-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are:

• 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.

Conditions

Solid Malignancies

Keywords

Metastatic or Recurrent Solid Malignancies

Outcome Measures

Primary Outcomes (5)

• PK parameter AUC of tisotumab vedotin

  To assess PK of tisotumab vedotin.PK parameters to be estimated will include area under the concentration-time curve (AUC).

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

• PK parameter Cmax of tisotumab vedotin

  To assess PK of tisotumab vedotin.PK parameters to be estimated will include maximum concentration (Cmax).

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

• PK parameter Tmax of tisotumab vedotin

  To assess PK of tisotumab vedotin.PK parameters to be estimated will include time to maximum concentration (Tmax).

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

• PK parameter t 1/2 of tisotumab vedotin

  To assess PK of tisotumab vedotin.PK parameters to be estimated will include apparent terminal half-life (t 1/2).

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

• PK parameter C trough of tisotumab vedotin

  To assess PK of tisotumab vedotin.PK parameters to be estimated will include trough concentration (C trough).

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

Secondary Outcomes (2)

• Immunogenicity of tisotumab vedotin.

  At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.

• Treatment-emergent adverse events (TEAEs) of tisotumab vedotin.

  Through study completion, an average of 1 year.

Other Outcomes (1)

• Objective response rate (ORR) of tisotumab vedotin.

  Through study completion, an average of 1 year.

Interventions

Tisotumab Vedotin DRUG

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

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

You may qualify if:

• Age ≥18 years.
• Must sign an informed consent form (ICF) .
• Must have recurrent or metastatic solid tumors and have failed on previous standard systemic therapy.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has life expectancy of at least 3 months.
• Must demonstrate acceptable screening laboratory values.
• 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.
• Any other toxicity caused by previous treatment should have recovered to ≤ CTCAE grade 1 or baseline level, except ≤ CTCAE grade 2 alopecia.

You may not qualify if:

• Has clinically significant bleeding issues or risks:
• Has cardiovascular issues or risks:
• Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \> 1 month prior to screening is allowed).
• Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
• Peripheral neuropathy ≥ grade 2.
• Any prior treatment with MMAE-derived drugs.
• 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.
• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shangdong, 250013, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

tisotumab vedotin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rutie Yin, Dr

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

• Guiling Li, Dr

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Bingzhong Zhang, Dr

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Qing Wen, Dr

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

• Meili Sun, Dr

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

• Jianhua Shi, Dr

  Linyi Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Dongqing Lv, Dr

  Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Tienan Yi, Dr

  Xiangyang Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 19, 2023
• Study Start: June 16, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)