Advanced Lung CancerEarly Phase 1NCT06106152
WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody
A Early Phase 1 study testing WTX212A injection and PD -1/PD-L1 monoclonal antibody in people with Advanced Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- WTX212A injection and PD -1/PD-L1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 31 Dec 2025
- Phase
- Early 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
- Regardless of gender, aged 18 to 75 years old (including threshold);
- Histologically or cytologically confirmed locally advanced (stage IIB/IIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with disease progression or intolerance after treatment or extensive stage small cell Lung cancer (SCLC)
- Patients with lung cancer who have been treated with at least 1 line system therapy or cannot currently receive standard therapy, and who have been treated with PD-1 or PD-L1 inhibitor antibody in the terminal line therapy regimen for ≥ 2 cycles;
- ECOG ≤1
- Expected life ≥ 3 months；
- Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration;
Who cannot join
- People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
- Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
- Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
- There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
- Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. Exceptions include early tumors that have received radical treatment (carcinoma in situ or grade 1 tumor, non ulcerative primary melanoma with a depth of less than 1mm and no lymph nodes involved), skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment;
- Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
- Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases;
- Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Pingli Wang, M.D, +86 135 1680 8409, pingliwang@zju.edu.cn
About this study
Official title: A Single-center, Open Label, Exploratory Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of WTX212A Injection Combined With PD -1/PD-L1 Monoclonal Antibody in Patients With Advanced Lung Cancer
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
Read the detailed description
The trial consist of Screening Period (30 days), Treatment Period (21*n days), Safety Follow-up Period (90 days) and Survival follow-up.
About 20 subjects are planned to be enrolled in the study.
- Conditions
- Advanced Lung Cancer
- Being tested
- WTX212A injection, PD -1/PD-L1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WTX212A injectionDrug
Also called autologous red blood cell PD-1 inhibitor conjugate
The WTX212A infusion is given every 21 days
PD -1/PD-L1 monoclonal antibodyDrug
Also called PD -1/PD-L1antibody
The PD -1/PD-L1 monoclonal antibody is given every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Fixed-dose in patients with advanced lung cancer | Experimental | WTX212A injection Fixed-dose in advanced lung cancer patients Receives: Drug: WTX212A injection |
| Combined Study in patients with advanced lung cancer | Experimental | Fixed-dose WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer Receives: Drug: WTX212A injection; Drug: PD -1/PD-L1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer.
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
Measured: 1 year
Secondary outcomes (3)
the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients
The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of WTX212A injection
Measured: 1 year
To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer
Peak Plasma Concentration (Cmax)
Measured: 1 year
To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients
Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 Dec 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label, exploratory study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake Therapeutics
- Responsible party
- Principal investigator, Pingli Wang, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- pingli wang, phD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106152
- Sponsor's protocol ID
- Reboot-105
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to disclose the data
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label, Exploratory Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of WTX212A Injection Combined With PD -1/PD-L1 Monoclonal Antibody in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06106152
- Acronym / sponsor ID
- Reboot-105
- Conditions
- Advanced Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Westlake Therapeutics
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Oct 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.
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
Detailed description
The trial consist of Screening Period (30 days), Treatment Period (21*n days), Safety Follow-up Period (90 days) and Survival follow-up.
About 20 subjects are planned to be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, open-label, exploratory study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
| Arm | Type | Receives |
|---|---|---|
| Fixed-dose in patients with advanced lung cancer | Experimental | Drug: WTX212A injectionWTX212A injection Fixed-dose in advanced lung cancer patients |
| Combined Study in patients with advanced lung cancer | Experimental | Drug: WTX212A injection, Drug: PD -1/PD-L1 monoclonal antibodyFixed-dose WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
- Regardless of gender, aged 18 to 75 years old (including threshold);
- Histologically or cytologically confirmed locally advanced (stage IIB/IIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with disease progression or intolerance after treatment or extensive stage small cell Lung cancer (SCLC)
- Patients with lung cancer who have been treated with at least 1 line system therapy or cannot currently receive standard therapy, and who have been treated with PD-1 or PD-L1 inhibitor antibody in the terminal line therapy regimen for ≥ 2 cycles;
- ECOG ≤1
Key exclusion criteria (8 listed)
- People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
- Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
- Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
- There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
- Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. Exceptions include early tumors that have received radical treatment (carcinoma in situ or grade 1 tumor, non ulcerative primary melanoma with a depth of less than 1mm and no lymph nodes involved), skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment;
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 |
|---|---|---|
| WTX212A injectionAlso: autologous red blood cell PD-1 inhibitor conjugateThe WTX212A infusion is given every 21 days | Drug | Combined Study in patients with advanced lung cancer, Fixed-dose in patients with advanced lung cancer |
| PD -1/PD-L1 monoclonal antibodyAlso: PD -1/PD-L1antibodyThe PD -1/PD-L1 monoclonal antibody is given every 21 days | Drug | Combined Study in patients with advanced lung cancer |
Primary outcome
To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer.
Time frame: 1 year
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
3 secondary outcomes
the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients
Time frame: 1 year
To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer
Time frame: 1 year
To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No. There are no plans to disclose the data
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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.
pingli wang, phD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WTX212A injection and PD -1/PD-L1 monoclonal antibody in people with Advanced Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pingli wang, phD ((0571)87783520, pingliwang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer. (time frame: 1 year). 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 26 Mar 2024.