Solid MalignanciesPhase 1NCT05866354
To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies
A Phase 1 study testing Tisotumab Vedotin in people with Solid Malignancies, run by Zai Lab (Shanghai) Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- Tisotumab Vedotin
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2023to 2 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
- Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
- Peripheral neuropathy ≥ grade 2.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies
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.
Read the detailed description
This is an open-label, phase 1, PK trial of intravenous tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors who have failed on previous standard systemic therapy. The screening period will be up to 28 days, after which eligible subjects 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.
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
- Solid Malignancies
- Being tested
- Tisotumab Vedotin
- Keywords
- Metastatic or Recurrent Solid Malignancies
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisotumab VedotinDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Anti-drug antibodies (ADAs) against tisotumab vedotin.
Measured: 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.
A TEAE is defined as a newly occurring or worsening AE from the first dose of study treatment to 30 days after the last dose of study treatment or initiation of new antitumor activities, whichever occurs first.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start16 Jun 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rutie Yin, Dr, Principal investigator, West China Second University HospitalGuiling Li, Dr, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyBingzhong Zhang, Dr, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityQing Wen, Dr, Principal investigator, Jinan Central HospitalMeili Sun, Dr, Principal investigator, Jinan Central HospitalJianhua Shi, Dr, Principal investigator, Linyi Cancer HospitalDongqing Lv, Dr, Principal investigator, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityTienan Yi, Dr, Principal investigator, Xiangyang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866354
- Sponsor's protocol ID
- ZL-1309-002
- Status last verified
- Nov 2023
- First submitted
- 27 Apr 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study close， the IPD will share to other researchers per the requirement from Zailab.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies
- ClinicalTrials.gov ID
- NCT05866354
- Acronym / sponsor ID
- ZL-1309-002
- Conditions
- Solid Malignancies
- Keywords
- Metastatic or Recurrent Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, phase 1, PK trial of intravenous tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors who have failed on previous standard systemic therapy. The screening period will be up to 28 days, after which eligible subjects 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
- 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.
- Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tisotumab VedotinTisotumab 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. | Drug | – |
Primary outcome
PK parameter AUC of tisotumab vedotin
Time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
To assess PK of tisotumab vedotin.PK parameters to be estimated will include area under the concentration-time curve (AUC).
PK parameter Cmax of tisotumab vedotin
Time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
To assess PK of tisotumab vedotin.PK parameters to be estimated will include maximum concentration (Cmax).
PK parameter Tmax of tisotumab vedotin
Time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
To assess PK of tisotumab vedotin.PK parameters to be estimated will include time to maximum concentration (Tmax).
PK parameter t 1/2 of tisotumab vedotin
Time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
To assess PK of tisotumab vedotin.PK parameters to be estimated will include apparent terminal half-life (t 1/2).
PK parameter C trough of tisotumab vedotin
Time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.
To assess PK of tisotumab vedotin.PK parameters to be estimated will include trough concentration (C trough).
2 secondary outcomes
Immunogenicity of tisotumab vedotin.
Time frame: 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.
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No. When the study close， the IPD will share to other researchers per the requirement from Zailab.
Related trials for Solid Malignancies
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rutie Yin, Dr principal investigator
West China Second University Hospital
Guiling Li, Dr principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Bingzhong Zhang, Dr principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tisotumab Vedotin in people with Solid Malignancies, run by Zai Lab (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameter AUC of tisotumab vedotin (time frame: At the end of Cycle 3 (each cycle is 21 days) of the last ongoing patient, about 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.