A Exploratory Trial of WTX212A Injection in the Treatment of Patients With Advanced Lung Cancer

Study Overview
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Brief Summary
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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 in patients with advanced lung cancer

Detailed Description
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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.

Official Title
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A Single-center, Open Label, Exploratory Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of WTX212A Injection in Patients With Advanced Lung Cancer

Conditions
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Advanced Lung Cancer

Intervention / Treatment
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* Drug: WTX212A injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed-dose in patients with advanced lung cancer<br>WTX212A injection Fixed-dose in advanced lung cancer patients | Drug: WTX212A injection<br>* The WTX212A infusion is given every 21 days<br>* Other names: autologous red blood cell PD-1 inhibitor conjugate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of WTX212A injection in the treatment of Immune checkpoint inhibitor resistance in advanced lung cancer patients | Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of WTX212A injection in the treatment of Immune checkpoint inhibitor resistance in 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 | 1 year | 
| To evaluate the Pharmacokinetic characteristics of WTX212A injection in the treatment of Immune checkpoint inhibitor resistance in advanced lung cancer patients | Peak Plasma Concentration (Cmax) | 1 year | 
| To evaluate the immunogenicity of WTX212A injection in the treatment of Immune checkpoint inhibitor resistance in advanced lung cancer patients | Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment | 1 year |